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Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03633227
Recruitment Status : Terminated (Due to Ocaliva (obeticholic acid) US labeling update, the sponsor decided to terminate the study.)
First Posted : August 16, 2018
Results First Posted : September 6, 2022
Last Update Posted : September 6, 2022
Sponsor:
Information provided by (Responsible Party):
Intercept Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Liver Cirrhosis, Biliary
Interventions Drug: Obeticholic Acid (OCA)
Drug: Placebo
Enrollment 22
Recruitment Details This study was conducted at study sites in the United States, Argentina, Belgium, Spain, Lithuania, Brazil, Australia, Germany, Estonia, Italy, Hungary, and Canada.
Pre-assignment Details A total of 31 participants were screened and 22 participants were randomized.
Arm/Group Title Placebo Obeticholic Acid (OCA)
Hide Arm/Group Description Participants received obeticholic acid (OCA) matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years). Participants initiated treatment with OCA 5 milligrams (mg) tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
Period Title: Double Blind (DB), up to Week 48
Started 12 10
Completed 4 6
Not Completed 8 4
Reason Not Completed
Withdrawal by Subject             1             1
Death             2             1
Adverse Event             0             1
Study Terminated by Sponsor             2             1
Physician Decision             1             0
Liver Transplant During the Course of the Study             1             0
Multiple Serious Adverse Events and Drug Interruptions             1             0
Period Title: DB Extension, Week 48 up to 3 Years
Started 4 6
Completed 0 0
Not Completed 4 6
Reason Not Completed
Withdrawal by Subject             0             2
Death             0             1
Study Terminated by Sponsor             3             2
Lost to Follow-up             1             0
Physician Decision             0             1
Arm/Group Title Placebo Obeticholic Acid (OCA) Total
Hide Arm/Group Description Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years). Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years). Total of all reporting groups
Overall Number of Baseline Participants 12 10 22
Hide Baseline Analysis Population Description
The Intent-to-treat (ITT) population included all randomized participants who received any amount of investigational product (OCA or placebo).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 10 participants 22 participants
62.5  (9.10) 60.5  (10.19) 61.6  (9.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
Female
10
  83.3%
6
  60.0%
16
  72.7%
Male
2
  16.7%
4
  40.0%
6
  27.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
Hispanic or Latino
6
  50.0%
4
  40.0%
10
  45.5%
Not Hispanic or Latino
6
  50.0%
6
  60.0%
12
  54.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
American Indian or Alaska Native
1
   8.3%
0
   0.0%
1
   4.5%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
11
  91.7%
10
 100.0%
21
  95.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Maximum Observed Concentration (Cmax) of Total OCA at Week 12
Hide Description Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. Pharmacokinetics (PK) of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population: participants who received OCA and had adequate concentration-time profile to characterize OCA and its conjugates and must not have had any major protocol deviations that potentially affect exposure level. Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis. No participant started OCA 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 5 0 0
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
293  (189)
2.Primary Outcome
Title Time to Maximum Concentration (Tmax) of Total OCA at Week 12
Hide Description Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 5 0 0
Median (Full Range)
Unit of Measure: hours
2.02
(2.00 to 3.00)
3.Primary Outcome
Title Trough Concentration (Ctrough) of Total OCA at Week 12
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 12. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time Frame 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 4 0 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
77.6  (49.7)
4.Primary Outcome
Title Area Under the Concentration Versus Time Curve From Zero Time to 24 Hours (AUC0-24h) of Total OCA at Week 12
Hide Description Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 4 0 0
Mean (Standard Deviation)
Unit of Measure: nanogram*hour per milliliter (ng*h/mL)
2970  (1650)
5.Primary Outcome
Title Cmax of Total OCA at Week 18
Hide Description Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
136  (77.6) 406  (120)
6.Primary Outcome
Title Tmax of Total OCA at Week 18
Hide Description Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Median (Full Range)
Unit of Measure: hours
0.750
(0.500 to 1.00)
2.52
(2.00 to 3.03)
7.Primary Outcome
Title Ctrough of Total OCA at Week 18
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 18. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time Frame 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
28.7  (13.6) 187  (147)
8.Primary Outcome
Title AUC0-24h of Total OCA at Week 18
Hide Description Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
1380  (776) 5810  (3600)
9.Primary Outcome
Title Cmax of Total OCA at Week 24
Hide Description Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
263  (261) 195 622  (117)
10.Primary Outcome
Title Tmax of Total OCA at Week 24
Hide Description Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Median (Full Range)
Unit of Measure: hours
5.04
(4.00 to 6.08)
0.750
(0.750 to 0.750)
2.27
(2.00 to 2.53)
11.Primary Outcome
Title Ctrough of Total OCA at Week 24
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 24. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time Frame 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
132  (163) 41.4 435  (28.6)
12.Primary Outcome
Title AUC0-24h of Total OCA at Week 24
Hide Description Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
4500  (4910) 2020 11300  (2950)
13.Primary Outcome
Title Cmax of Total OCA at Week 30
Hide Description Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
125 277  (64.7) 674  (310)
14.Primary Outcome
Title Tmax of Total OCA at Week 30
Hide Description Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Median (Full Range)
Unit of Measure: hours
1.00
(1.00 to 1.00)
4.52
(4.03 to 5.00)
3.77
(2.53 to 5.00)
15.Primary Outcome
Title Ctrough of Total OCA at Week 30
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 30. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time Frame 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
22.3 217  (15.7) 317  (248)
16.Primary Outcome
Title AUC0-24h of Total OCA at Week 30
Hide Description Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
1260 5040  (855) 10500  (7000)
17.Primary Outcome
Title Cmax of Total OCA at Week 48
Hide Description Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
200  (15.1) 728  (27.5)
18.Primary Outcome
Title Tmax of Total OCA at Week 48
Hide Description Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Median (Full Range)
Unit of Measure: hours
1.73
(1.47 to 2.00)
4.03
(2.00 to 6.05)
19.Primary Outcome
Title Ctrough of Total OCA at Week 48
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 48. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.
Time Frame 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
88.3  (29.9) 497  (135)
20.Primary Outcome
Title AUC0-24h of Total OCA at Week 48
Hide Description Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
3210  (56.7) 13900  (452)
21.Primary Outcome
Title Cmax of Unconjugated OCA at Week 12
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 5 0 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
107  (62.0)
22.Primary Outcome
Title Tmax of Unconjugated OCA at Week 12
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 5 0 0
Median (Full Range)
Unit of Measure: hours
1.43
(1.00 to 1.50)
23.Primary Outcome
Title Ctrough of Unconjugated OCA at Week 12
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 12.
Time Frame 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 4 0 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
2.92  (2.51)
24.Primary Outcome
Title AUC0-24h of Unconjugated OCA at Week 12
Hide Description AUC0-24 was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 3 0 0
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
278  (142)
25.Primary Outcome
Title Cmax of Unconjugated OCA at Week 18
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
107  (47.4) 109  (90.3)
26.Primary Outcome
Title Tmax of Unconjugated OCA at Week 18
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Median (Full Range)
Unit of Measure: hours
0.750
(0.500 to 1.00)
1.24
(1.00 to 1.48)
27.Primary Outcome
Title Ctrough of Unconjugated OCA at Week 18
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 18.
Time Frame 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
3.38  (0.262) 3.56  (4.01)
28.Primary Outcome
Title AUC0-24h of Unconjugated OCA at Week 18
Hide Description AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
191  (125) 263  (247)
29.Primary Outcome
Title Cmax of Unconjugated OCA at Week 24
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
115  (98.2) 157 168  (92.6)
30.Primary Outcome
Title Tmax of Unconjugated OCA at Week 24
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Median (Full Range)
Unit of Measure: hours
1.13
(0.750 to 1.50)
0.500
(0.500 to 0.500)
1.63
(1.58 to 1.67)
31.Primary Outcome
Title Ctrough of Unconjugated OCA at Week 24
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 24.
Time Frame 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
2.46  (2.05) 5.18 8.77  (11.4)
32.Primary Outcome
Title AUC0-24h of Unconjugated OCA at Week 24
Hide Description AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
235  (130) 345 480  (414)
33.Primary Outcome
Title Cmax of Unconjugated OCA at Week 30
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
92.6 132  (24.0) 115  (40.9)
34.Primary Outcome
Title Tmax of Unconjugated OCA at Week 30
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Median (Full Range)
Unit of Measure: hours
0.750
(0.750 to 0.750)
1.17
(1.00 to 1.33)
1.75
(0.500 to 3.00)
35.Primary Outcome
Title Ctrough of Unconjugated OCA at Week 30
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 30.
Time Frame 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
3.03 4.27  (4.85) 3.20  (3.14)
36.Primary Outcome
Title AUC0-24h of Unconjugated OCA at Week 30
Hide Description AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
176 304  (82.3) 473  (397)
37.Primary Outcome
Title Cmax of Unconjugated OCA at Week 48
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
131  (31.8) 284  (177)
38.Primary Outcome
Title Tmax of Unconjugated OCA at Week 48
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Median (Full Range)
Unit of Measure: hours
1.10
(0.700 to 1.50)
0.500
(0.500 to 0.500)
39.Primary Outcome
Title Ctrough of Unconjugated OCA at Week 48
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 48.
Time Frame 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
3.43  (3.90) 4.72  (6.67)
40.Primary Outcome
Title AUC0-24h of Unconjugated OCA at Week 48
Hide Description AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 1
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
376  (118) 1190
41.Primary Outcome
Title Cmax of Glyco Conjugate of OCA (Glyco-OCA) at Week 12
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 5 0 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
117  (55.0)
42.Primary Outcome
Title Tmax of Glyco-OCA at Week 12
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 5 0 0
Median (Full Range)
Unit of Measure: hours
5.00
(3.92 to 5.00)
43.Primary Outcome
Title Ctrough of Glyco-OCA at Week 12
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 12.
Time Frame 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 4 0 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
47.1  (31.1)
44.Primary Outcome
Title AUC0-24h of Glyco-OCA at Week 12
Hide Description AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 4 0 0
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
1690  (947)
45.Primary Outcome
Title Metabolite to Parent Ratio of AUC-0-24h (MRAUC) of Glyco-OCA at Week 12
Hide Description MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 3 0 0
Mean (Standard Deviation)
Unit of Measure: ratio
4.36  (1.03)
46.Primary Outcome
Title Metabolite to Parent Ratio of Cmax (MRCmax) of Glyco-OCA at Week 12
Hide Description MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 5 0 0
Mean (Standard Deviation)
Unit of Measure: ratio
1.39  (1.38)
47.Primary Outcome
Title Cmax of Glyco-OCA at Week 18
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
52.7  (4.31) 213  (22.6)
48.Primary Outcome
Title Tmax of Glyco-OCA at Week 18
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Median (Full Range)
Unit of Measure: hours
4.25
(2.50 to 6.00)
2.52
(2.00 to 3.03)
49.Primary Outcome
Title Ctrough of Glyco-OCA at Week 18
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 18.
Time Frame 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
13.3  (5.03) 98.1  (53.7)
50.Primary Outcome
Title AUC0-24h of Glyco-OCA at Week 18
Hide Description AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
625  (147) 3020  (1120)
51.Primary Outcome
Title MRAUC of Glyco-OCA at Week 18
Hide Description MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ratio
3.39  (1.55) 21.2  (23.6)
52.Primary Outcome
Title MRCmax of Glyco-OCA at Week 18
Hide Description MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ratio
0.487  (0.250) 2.73  (2.44)
53.Primary Outcome
Title Cmax of Glyco-OCA at Week 24
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
166  (163) 56.2 294  (70.0)
54.Primary Outcome
Title Tmax of Glyco-OCA at Week 24
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Median (Full Range)
Unit of Measure: hours
5.04
(4.00 to 6.08)
5.00
(5.00 to 5.00)
4.54
(4.08 to 5.00)
55.Primary Outcome
Title Ctrough of Glyco-OCA at Week 24
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 24.
Time Frame 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
83.0  (106) 22.0 239  (7.07)
56.Primary Outcome
Title AUC0-24h of Glyco-OCA at Week 24
Hide Description AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
2710  (3030) 936 5550  (878)
57.Primary Outcome
Title MRAUC of Glyco-OCA at Week 24
Hide Description MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ratio
8.26  (6.80) 2.39 17.3  (16.5)
58.Primary Outcome
Title MRCmax of Glyco-OCA at Week 24
Hide Description MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ratio
1.17  (0.253) 0.315 1.94  (1.44)
59.Primary Outcome
Title Cmax of Glyco-OCA at Week 30
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
83.0 174  (75.0) 301  (86.3)
60.Primary Outcome
Title Tmax of Glyco-OCA at Week 30
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Median (Full Range)
Unit of Measure: hours
6.00
(6.00 to 6.00)
14.0
(4.03 to 24.0)
4.51
(4.02 to 5.00)
61.Primary Outcome
Title Ctrough of Glyco-OCA at Week 30
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 30.
Time Frame 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
14.4 143  (30.4) 156  (79.4)
62.Primary Outcome
Title AUC0-24h of Glyco-OCA at Week 30
Hide Description AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
863 3180  (1080) 5050  (2260)
63.Primary Outcome
Title MRAUC of Glyco-OCA at Week 30
Hide Description MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ratio
4.31 10.0  (5.84) 17.2  (18.7)
64.Primary Outcome
Title MRCmax of Glyco-OCA at Week 30
Hide Description MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ratio
0.789 1.23  (0.723) 2.58  (1.58)
65.Primary Outcome
Title Cmax of Glyco-OCA at Week 48
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
123  (34.0) 354  (37.5)
66.Primary Outcome
Title Tmax of Glyco-OCA at Week 48
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Median (Full Range)
Unit of Measure: hours
5.00
(5.00 to 5.00)
4.03
(2.00 to 6.05)
67.Primary Outcome
Title Ctrough of Glyco-OCA at Week 48
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 48.
Time Frame 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
65.9  (10.2) 280  (62.2)
68.Primary Outcome
Title AUC0-24h of Glyco-OCA at Week 48
Hide Description AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
2120  (422) 6950  (648)
69.Primary Outcome
Title MRAUC of Glyco-OCA at Week 48
Hide Description MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 1
Mean (Standard Deviation)
Unit of Measure: ratio
5.39  (2.69) 4.79
70.Primary Outcome
Title MRCmax of Glyco-OCA at Week 48
Hide Description MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Mean (Standard Deviation)
Unit of Measure: ratio
0.826  (0.0280) 1.41  (1.00)
71.Primary Outcome
Title Cmax of Tauro Conjugate of OCA (Tauro-OCA) at Week 12
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 5 0 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
201  (213)
72.Primary Outcome
Title Tmax of Tauro-OCA at Week 12
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 5 0 0
Median (Full Range)
Unit of Measure: hours
5.00
(3.00 to 5.00)
73.Primary Outcome
Title Ctrough of Tauro-OCA at Week 12
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 12.
Time Frame 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 4 0 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
41.6  (33.0)
74.Primary Outcome
Title AUC0-24h of Tauro-OCA at Week 12
Hide Description AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 4 0 0
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
1580  (1260)
75.Primary Outcome
Title MRAUC of Tauro-OCA at Week 12
Hide Description MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 3 0 0
Mean (Standard Deviation)
Unit of Measure: ratio
3.13  (1.08)
76.Primary Outcome
Title MRCmax of Tauro-OCA at Week 12
Hide Description MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 5 0 0
Mean (Standard Deviation)
Unit of Measure: ratio
2.24  (2.46)
77.Primary Outcome
Title Cmax of Tauro-OCA at Week 18
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
63.2  (46.9) 221  (188)
78.Primary Outcome
Title Tmax of Tauro-OCA at Week 18
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Median (Full Range)
Unit of Measure: hours
5.00
(5.00 to 5.00)
2.52
(2.00 to 3.03)
79.Primary Outcome
Title Ctrough of Tauro-OCA at Week 18
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 18.
Time Frame 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
17.0  (11.2) 122  (130)
80.Primary Outcome
Title AUC0-24h of Tauro-OCA at Week 18
Hide Description AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
799  (654) 3630  (3600)
81.Primary Outcome
Title MRAUC of Tauro-OCA at Week 18
Hide Description MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ratio
3.11  (0.685) 28.8  (37.9)
82.Primary Outcome
Title MRCmax of Tauro-OCA at Week 18
Hide Description MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ratio
0.434  (0.156) 3.32  (4.12)
83.Primary Outcome
Title Cmax of Tauro-OCA at Week 24
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
142  (144) 65.5 430  (142)
84.Primary Outcome
Title Tmax of Tauro-OCA at Week 24
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Median (Full Range)
Unit of Measure: hours
5.54
(5.00 to 6.08)
9.00
(9.00 to 9.00)
4.05
(3.10 to 5.00)
85.Primary Outcome
Title Ctrough of Tauro-OCA at Week 24
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 24.
Time Frame 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
71.0  (90.5) 21.2 271  (58.0)
86.Primary Outcome
Title AUC0-24h of Tauro-OCA at Week 24
Hide Description AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
2360  (2650) 1060 7470  (3260)
87.Primary Outcome
Title MRAUC of Tauro-OCA at Week 24
Hide Description MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ratio
6.51  (5.40) 2.46 23.4  (25.6)
88.Primary Outcome
Title MRCmax of Tauro-OCA at Week 24
Hide Description MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 1 2
Mean (Standard Deviation)
Unit of Measure: ratio
0.881  (0.249) 0.332 2.63  (2.13)
89.Primary Outcome
Title Cmax of Tauro-OCA at Week 30
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
38.6 141  (13.4) 460  (342)
90.Primary Outcome
Title Tmax of Tauro-OCA at Week 30
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Median (Full Range)
Unit of Measure: hours
6.00
(6.00 to 6.00)
4.52
(4.03 to 5.00)
4.03
(3.05 to 5.00)
91.Primary Outcome
Title Ctrough of Tauro-OCA at Week 30
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 30.
Time Frame 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
8.21 110  (7.78) 222  (228)
92.Primary Outcome
Title AUC0-24h of Tauro-OCA at Week 30
Hide Description AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
408 2430  (18.1) 7020  (6780)
93.Primary Outcome
Title MRAUC of Tauro-OCA at Week 30
Hide Description MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ratio
1.84 6.61  (1.74) 25.7  (33.0)
94.Primary Outcome
Title MRCmax of Tauro-OCA at Week 30
Hide Description MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 1 2 2
Mean (Standard Deviation)
Unit of Measure: ratio
0.332 0.855  (0.0746) 3.85  (3.73)
95.Primary Outcome
Title Cmax of Tauro-OCA at Week 48
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
72.5  (15.1) 485  (20.5)
96.Primary Outcome
Title Tmax of Tauro-OCA at Week 48
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Median (Full Range)
Unit of Measure: hours
6.50
(6.00 to 7.00)
2.57
(2.00 to 3.13)
97.Primary Outcome
Title Ctrough of Tauro-OCA at Week 48
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 48.
Time Frame 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
33.7  (21.4) 309  (109)
98.Primary Outcome
Title AUC0-24h of Tauro-OCA at Week 48
Hide Description AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
1220  (389) 8890  (696)
99.Primary Outcome
Title MRAUC of Tauro-OCA at Week 48
Hide Description MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 1
Mean (Standard Deviation)
Unit of Measure: ratio
2.59  (0.00903) 5.60
100.Primary Outcome
Title MRCmax of Tauro-OCA at Week 48
Hide Description MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 0 2 2
Mean (Standard Deviation)
Unit of Measure: ratio
0.468  (0.206) 1.67  (0.989)
101.Primary Outcome
Title Cmax of Glucuronide Metabolite of OCA (OCA-glucuronide) at Week 12
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 5 0 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
47.0  (24.7)
102.Primary Outcome
Title Tmax of OCA-glucuronide at Week 12
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 5 0 0
Median (Full Range)
Unit of Measure: hours
2.50
(1.50 to 3.00)
103.Primary Outcome
Title Ctrough of OCA-glucuronide at Week 12
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 12.
Time Frame 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 4 0 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
20.7  (15.4)
104.Primary Outcome
Title AUC0-24h of OCA-glucuronide at Week 12
Hide Description AUC0-24h was calculated using the linear/linear trapezoidal rule.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 4 0 0
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
593  (388)
105.Primary Outcome
Title MRAUC of OCA-glucuronide at Week 12
Hide Description MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 3 0 0
Mean (Standard Deviation)
Unit of Measure: ratio
1.17  (0.638)
106.Primary Outcome
Title MRCmax of OCA-glucuronide at Week 12
Hide Description MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 5 0 0
Mean (Standard Deviation)
Unit of Measure: ratio
0.384  (0.275)
107.Primary Outcome
Title Cmax of OCA-glucuronide at Week 18
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
39.2  (30.3) 74.9  (38.4)
108.Primary Outcome
Title Tmax of OCA-glucuronide at Week 18
Hide Description [Not Specified]
Time Frame Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Median (Full Range)
Unit of Measure: hours
1.25
(1.00 to 1.50)
2.73
(1.50 to 3.97)
109.Primary Outcome
Title Ctrough of OCA-glucuronide at Week 18
Hide Description Ctrough was considered as the concentration at 24-hours post-dose at Week 18.
Time Frame 24 hours post-dose at Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.
Arm/Group Title OCA 5 mg Once Weekly OCA 5 mg Twice Weekly OCA 10 mg Twice Weekly
Hide Arm/Group Description:
Participants received OCA 5 mg tablets orally once weekly.
Participants received OCA 5 mg tablets orally twice weekly.
Participants received OCA 10 mg tablets orally twice weekly.
Overall Number of Participants Analyzed 2 2 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
11.7  (7.55) 40.9  (43.9)
110.Primary Outcome