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Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics

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ClinicalTrials.gov Identifier: NCT02654002
Recruitment Status : Completed
First Posted : January 13, 2016
Results First Posted : October 12, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Nonalcoholic Steatohepatitis (NASH)
Interventions Drug: Cilofexor
Drug: Placebo
Enrollment 120
Recruitment Details Participants were enrolled at one study site in the United States. The first participant was screened on 20 January 2016. The last study visit occurred on 14 July 2016.
Pre-assignment Details 183 participants were screened. No participants were enrolled in Cohorts 9 and 10.
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg All Placebo
Hide Arm/Group Description Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20. Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20. Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20. Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20. Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20. Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20. Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20. Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20. Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
Period Title: Overall Study
Started 12 12 12 12 12 12 12 12 24
Completed 12 12 12 12 12 11 11 11 24
Not Completed 0 0 0 0 0 1 1 1 0
Reason Not Completed
Adverse Event             0             0             0             0             0             0             1             0             0
Withdrew Consent             0             0             0             0             0             1             0             1             0
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg All Placebo Total
Hide Arm/Group Description Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20. Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20. Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20. Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20. Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20. Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20. Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20. Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20. Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20. Total of all reporting groups
Overall Number of Baseline Participants 12 12 12 12 12 11 12 11 24 118
Hide Baseline Analysis Population Description
The Safety Analysis Set included all randomized participants who took at least 1 dose of study drug. Participants were grouped according to the treatment they actually received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants 118 participants
34  (6.5) 35  (8.9) 37  (6.1) 32  (8.7) 40  (4.6) 33  (7.4) 35  (6.0) 35  (7.1) 36  (6.7) 35  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants 118 participants
Female 6 4 5 4 5 6 7 8 14 59
Male 6 8 7 8 7 5 5 3 10 59
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants 118 participants
Hispanic or Latino 11 12 11 12 12 11 12 11 24 116
Not Hispanic or Latino 1 0 1 0 0 0 0 0 0 2
Unknown or Not Reported 0 0 0 0 0 0 0 0 0 0
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants 118 participants
Black 1 1 2 3 2 2 1 2 2 16
White 11 11 10 9 10 9 11 9 22 102
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants 118 participants
12 12 12 12 12 11 12 11 24 118
1.Primary Outcome
Title Single-Dose Pharmacokinetic (PK) Parameter: AUClast of Cilofexor
Hide Description AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.
Time Frame Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Analysis Set included all randomized participants who took at least 1 dose of Cilofexor and had at least 1 non-missing post-dose concentration value reported by the PK laboratory for each corresponding analyte.
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg
Hide Arm/Group Description:
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Overall Number of Participants Analyzed 12 12 12 12 12 11 12 11
Mean (Standard Deviation)
Unit of Measure: hours*nanogram/millilitre (h*ng/mL)
1236.0  (384.65) 2450.6  (921.70) 7712.1  (7270.76) 12458.8  (4223.12) 4979.5  (2039.07) 3091.4  (752.66) 1301.9  (388.51) 905.9  (210.24)
2.Primary Outcome
Title Single-Dose PK Parameter: AUCinf of Cilofexor
Hide Description AUCinf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).
Time Frame Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set were analyzed.
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg
Hide Arm/Group Description:
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Overall Number of Participants Analyzed 12 12 12 12 12 11 12 11
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
1255.9  (382.37) 2473.4  (920.85) 7743.7  (7273.50) 12495.7  (4230.00) 5016.7  (2022.94) 3559.2  (1092.73) 1409.3  (428.33) 924.0  (216.60)
3.Primary Outcome
Title Single-Dose PK Parameter: Cmax of Cilofexor
Hide Description Cmax is defined as the maximum observed concentration of drug in plasma.
Time Frame Day 1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set were analyzed.
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg
Hide Arm/Group Description:
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Overall Number of Participants Analyzed 12 12 12 12 12 11 12 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
304.2  (126.66) 580.2  (283.79) 2592.3  (3059.31) 3055.5  (2022.27) 927.6  (540.94) 665.9  (152.30) 340.2  (124.44) 209.8  (63.24)
4.Primary Outcome
Title Multiple-Dose PK Parameter: AUCtau of Cilofexor
Hide Description AUCtau is the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).
Time Frame Day 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set were analyzed.
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg
Hide Arm/Group Description:
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Overall Number of Participants Analyzed 12 12 12 12 12 11 11 11
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
1284.9  (460.35) 2891.0  (680.10) 6719.4  (3980.90) 8486.0  (4139.86) 4182.7  (1956.03) 3698.3  (837.91) 1293.5  (250.95) 848.2  (213.82)
5.Primary Outcome
Title Multiple-Dose PK Parameter: Cmax of Cilofexor
Hide Description Cmax is defined as the maximum observed concentration of drug in plasma.
Time Frame Day 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set with available data were analyzed.
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg
Hide Arm/Group Description:
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Overall Number of Participants Analyzed 12 12 12 12 12 11 11 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
322.2  (136.70) 717.5  (235.50) 2231.2  (1693.78) 2327.9  (1897.48) 818.7  (437.28) 697.8  (145.60) 290.4  (78.71) 187.0  (57.10)
6.Primary Outcome
Title Multiple-Dose PK Parameter: Ctau of Cilofexor
Hide Description Ctau is defined as the observed drug concentration at the end of the dosing interval.
Time Frame Day 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set with available data were analyzed.
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg
Hide Arm/Group Description:
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Overall Number of Participants Analyzed 12 12 12 12 12 11 11 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
2.7  (1.53) 7.9  (3.97) 36.3  (15.44) 70.1  (39.46) 22.6  (8.44) 107.6  (84.58) 28.4  (14.13) 3.0  (1.54)
7.Primary Outcome
Title Percentage of Participants With at Least One Adverse Event (AE)
Hide Description An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame First dose date up to last dose date (Maximum: 20 days) plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included all randomized participants who took at least 1 dose of study drug. Participants were grouped according to the treatment they actually received.
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg All Placebo
Hide Arm/Group Description:
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
Overall Number of Participants Analyzed 12 12 12 12 12 11 12 11 24
Measure Type: Number
Unit of Measure: percentage of participants
33.3 25.0 33.3 25.0 41.7 27.3 75.0 18.2 29.2
8.Primary Outcome
Title Percentage of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
Hide Description Investigator determined the ECG findings were clinically significant.
Time Frame First dose date up to last dose date (Maximum: 20 days) plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set were analyzed. Participants were grouped according to the treatment they actually received.
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg All Placebo
Hide Arm/Group Description:
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then receive cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then receive cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then receive cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then receive cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then receive cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then receive placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
Overall Number of Participants Analyzed 12 12 12 12 12 11 12 11 24
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 0 0 0 0 0 0
9.Primary Outcome
Title Percentage of Participants With Clinical Laboratory Abnormalities
Hide Description Treatment-emergent laboratory (Hematology, Chemistry, and Urinalysis) abnormalities were defined as values that increase at least one toxicity grade from baseline. Laboratory Abnormalities are graded by the investigator as Grade 1, 2, 3, or 4 according to the modified Gilead Sciences, Inc (GSI) Grading Scale. The most severe graded abnormality from all tests was counted for each participant. Data is only reported for those Grades reported in 1 or more participants.
Time Frame First dose date up to last dose date (Maximum: 20 days) plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed. Participants were grouped according to the treatment they actually received.
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg All Placebo
Hide Arm/Group Description:
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
Overall Number of Participants Analyzed 12 12 12 12 12 11 12 11 24
Measure Type: Number
Unit of Measure: percentage of participants
Activated Partial Thromboplastin Time: Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 8.3 16.7 0.0 0.0 0.0 0.0 0.0 0.0
Hemoglobin-Hypo: Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
16.7 25.0 16.7 8.3 16.7 18.2 25.0 27.3 29.2
Hemoglobin-Hypo: Grade 2 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 8.3 8.3 8.3 0.0 16.7 9.1 8.3
Hemoglobin-Hypo: Grade 3 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 0.0 8.3 0.0 0.0 0.0 0.0 0.0
International Normalized Ratio: Grade 2 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 0.0 0.0 8.3 0.0 0.0 0.0 0.0
Lymphocytes: Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 8.3 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Platelets: Grade 2 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 8.3 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Alanine Aminotransferase: Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 0.0 8.3 0.0 0.0 0.0 9.1 4.2
Alanine Aminotransferase: Grade 2 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 16.7 0.0 0.0 8.3 9.1 0.0 0.0 4.2
Alanine Aminotransferase: Grade 3 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 0.0 0.0 0.0 0.0 8.3 0.0 0.0
Aspartate Aminotransferase: Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 0.0 0.0 8.3 9.1 0.0 0.0 4.2
Aspartate Aminotransferase: Grade 2 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 8.3 0.0 0.0 0.0 0.0 8.3 0.0 0.0
Aspartate Aminotransferase: Grade 3 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 8.3 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Aspartate Aminotransferase: Grade 4 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 4.2
Albumin Corrected Calcium-Hyper: Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 0.0 8.3 8.3 9.1 8.3 0.0 4.2
Gamma-Glutamyltransferase: Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 8.3 0.0 0.0 0.0 0.0 0.0 4.2
Gamma-Glutamyltransferase: Grade 2 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 0.0 0.0 0.0 0.0 8.3 0.0 0.0
Low-Density Lipoprotein: Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
8.3 0.0 8.3 8.3 25.0 27.3 25.0 18.2 12.5
Low-Density Lipoprotein: Grade 2 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
8.3 8.3 8.3 8.3 16.7 0.0 8.3 0.0 4.2
Phosphate-Hypo: Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 8.3 0.0 8.3 8.3 0.0 8.3 9.1 4.2
Phosphate-Hypo: Grade 2 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 4.2
Serum Amylase: Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 8.3 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Serum Amylase: Grade 2 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 0.0 0.0 0.0 0.0 0.0 9.1 4.2
Serum Glucose,Fasting-Hyper: Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 8.3 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Serum Glucose,Fasting-Hyper:Grade 2 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 0.0 0.0 0.0 0.0 0.0 9.1 0.0
Serum Glucose,Non-Fasting-Hyper:Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 11 participants 11 participants 24 participants
0.0 0.0 0.0 0.0 58.3 0.0 18.2 0.0 4.2
Serum Glucose,Non-Fasting-Hyper:Grade 2 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 11 participants 11 participants 24 participants
0.0 0.0 0.0 0.0 0.0 0.0 0.0 9.1 0.0
Serum Glucose,Non-Fasting-Hypo:Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 0.0 0.0 8.3 0.0 0.0 0.0 4.2
Serum Potassium-Hypo:Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 8.3 0.0 0.0 0.0 0.0 0.0 27.3 0.0
Serum Sodium-Hyper:Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 0.0 0.0 0.0 0.0 0.0 9.1 0.0
Serum Sodium-Hypo:Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
8.3 25.0 8.3 0.0 0.0 18.2 50.0 9.1 4.2
Total Bilirubin-Hyper:Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 0.0 8.3 0.0 0.0 0.0 9.1 4.2
Total Cholesterol-Hyper:Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
16.7 0.0 16.7 16.7 25.0 36.4 25.0 9.1 12.5
Total Cholesterol-Hyper:Grade 2 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
8.3 0.0 8.3 0.0 16.7 0.0 8.3 9.1 4.2
Uric Acid-Hyper:Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 8.3 0.0 0.0 0.0 0.0 0.0 0.0
Uric Acid-Hypo:Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
8.3 16.7 0.0 8.3 0.0 0.0 0.0 0.0 0.0
Occult Blood: Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 8.3 0.0 8.3 0.0 0.0 9.1 8.3
Occult Blood: Grade 2 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
16.7 8.3 0.0 8.3 0.0 0.0 0.0 9.1 12.5
Occult Blood: Grade 3 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
25.0 8.3 8.3 16.7 8.3 18.2 16.7 18.2 8.3
Urine Glucose: Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 0.0 0.0 0.0 0.0 0.0 0.0 9.1 0.0
Urine Protein: Grade 1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 24 participants
0.0 8.3 0.0 0.0 0.0 0.0 0.0 0.0 4.2
10.Secondary Outcome
Title Pharmacodynamic (PD) Parameter: Fibroblast Growth Factor 19 (FGF19) AUC2-12 Ratio
Hide Description AUC2-12 is defined as the AUC from time 2 to 12 hours. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the AUC2-12 Day 1 /AUC2-12 Day-1. The ratio reported for Day 20 is the AUC2-12 Day 20 /AUC2-12 Day-1.
Time Frame Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
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Hide Analysis Population Description
The PD Analysis Set included all randomized participants who received at least 1 dose of study drug and had the necessary baseline and on-study measurement to provide interpretable results for each respective PD parameter. Included participants with available data.
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg All Fasted Placebo Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg All Fed Placebo
Hide Arm/Group Description:
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state (cohorts 1-4) received placebo tablet(s), orally, once on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once daily from Day 7 to Day 20.
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
Overall Number of Participants Analyzed 12 12 12 12 12 12 11 12 11 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
Day 1/Day -1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 12 participants
2.040
(1.571 to 2.650)
1.958
(1.478 to 2.594)
2.037
(1.699 to 2.442)
2.314
(1.958 to 2.735)
0.981
(0.777 to 1.240)
2.406
(2.196 to 2.637)
2.629
(2.369 to 2.917)
1.743
(1.463 to 2.076)
1.372
(1.132 to 1.663)
0.916
(0.799 to 1.050)
Day 20/Day -1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 11 participants 11 participants 12 participants
2.270
(1.500 to 3.435)
2.261
(1.782 to 2.868)
2.054
(1.727 to 2.442)
2.179
(1.632 to 2.911)
1.249
(0.929 to 1.681)
1.795
(1.544 to 2.086)
2.119
(1.728 to 2.598)
1.650
(1.301 to 2.093)
1.509
(1.325 to 1.719)
0.963
(0.762 to 1.216)
11.Secondary Outcome
Title PD Parameter: FGF19 Cmax Ratio
Hide Description Cmax is defined as the maximum observed concentration of FGF19 in plasma. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the Cmax Day 1 /Cmax Day-1. The ratio reported for Day 20 is the Cmax Day 20 /Cmax Day-1.
Time Frame Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PD Analysis Set with available data were analyzed.
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg All Fasted Placebo Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg All Fed Placebo
Hide Arm/Group Description:
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state (cohorts 1-4) received placebo tablet(s), orally, once on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once daily from Day 7 to Day 20.
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
Overall Number of Participants Analyzed 12 12 12 12 12 12 11 12 11 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
Day 1/Day -1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 12 participants
2.217
(1.667 to 2.949)
2.084
(1.468 to 2.957)
2.259
(1.742 to 2.930)
2.679
(2.113 to 3.398)
0.982
(0.759 to 1.272)
2.793
(2.264 to 3.446)
2.973
(2.578 to 3.428)
1.961
(1.588 to 2.422)
1.689
(1.354 to 2.106)
0.929
(0.810 to 1.065)
Day 20/Day -1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 11 participants 11 participants 12 participants
2.157
(1.345 to 3.460)
2.393
(1.770 to 3.235)
2.325
(1.804 to 2.996)
3.084
(2.194 to 4.334)
1.210
(0.910 to 1.608)
2.241
(1.850 to 2.713)
2.455
(1.964 to 3.069)
1.768
(1.270 to 2.462)
1.878
(1.527 to 2.310)
0.874
(0.680 to 1.123)
12.Secondary Outcome
Title PD Parameter: 7alpha-hydroxy-4-cholesten-3-one (C4) AUC2-12 Ratio
Hide Description AUC2-12 is defined as the AUC from time 2 to 12 hours. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the AUC2-12 Day 1 /AUC2-12 Day-1. The ratio reported for Day 20 is the AUC2-12 Day 20 /AUC2-12 Day-1.
Time Frame Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PD Analysis Set with available data were analyzed.
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg All Fasted Placebo Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg All Fed Placebo
Hide Arm/Group Description:
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state (cohorts 1-4) received placebo tablet(s), orally, once on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once daily from Day 7 to Day 20.
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
Overall Number of Participants Analyzed 12 12 12 12 12 12 11 12 11 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
Day 1/Day -1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 12 participants
0.681
(0.431 to 1.077)
0.640
(0.516 to 0.794)
0.427
(0.340 to 0.537)
0.347
(0.278 to 0.433)
1.147
(0.921 to 1.429)
0.837
(0.629 to 1.114)
0.653
(0.581 to 0.735)
0.863
(0.747 to 0.997)
1.108
(0.828 to 1.483)
1.057
(0.893 to 1.252)
Day 20/Day -1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 11 participants 11 participants 12 participants
0.661
(0.456 to 0.959)
0.382
(0.277 to 0.525)
0.495
(0.348 to 0.704)
0.325
(0.223 to 0.474)
1.213
(0.828 to 1.777)
0.621
(0.414 to 0.933)
0.173
(0.109 to 0.275)
0.624
(0.472 to 0.825)
0.974
(0.677 to 1.402)
0.843
(0.681 to 1.043)
13.Secondary Outcome
Title PD Parameter: C4 Cmin Ratio
Hide Description Cmin is defined as the minimum observed concentration of C4 in plasma. The ratios calculated were normalized to Day -1. Participants received a single placebo tablet at Day -1 for Baseline. The ratio reported for Day 1 is the Cmin Day 1 /Cmin Day-1. The ratio reported for Day 20 is the Cmin Day 20 /Cmin Day-1.
Time Frame Day -1: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, and 16 hours post-dose; Days 1, and 20: -0.5, 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, and 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PD Analysis Set with available data were analyzed.
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg All Fasted Placebo Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg All Fed Placebo
Hide Arm/Group Description:
Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fasted state (cohorts 1-4) received placebo tablet(s), orally, once on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once daily from Day 7 to Day 20.
Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20.
Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20.
Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20.
Participants in fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
Overall Number of Participants Analyzed 12 12 12 12 12 12 11 12 11 12
Geometric Mean (95% Confidence Interval)
Unit of Measure: ratio
Day 1/Day -1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 12 participants 11 participants 12 participants
0.715
(0.531 to 0.964)
0.759
(0.597 to 0.964)
0.663
(0.542 to 0.810)
0.467
(0.370 to 0.589)
1.201
(0.941 to 1.532)
0.613
(0.497 to 0.756)
0.348
(0.260 to 0.467)
0.737
(0.590 to 0.921)
0.961
(0.787 to 1.173)
1.162
(0.981 to 1.377)
Day 20/Day -1 Number Analyzed 12 participants 12 participants 12 participants 12 participants 12 participants 12 participants 11 participants 11 participants 11 participants 12 participants
0.822
(0.580 to 1.163)
0.456
(0.303 to 0.687)
0.624
(0.458 to 0.850)
0.432
(0.277 to 0.675)
1.262
(0.901 to 1.767)
0.440
(0.264 to 0.733)
0.116
(0.071 to 0.192)
0.508
(0.334 to 0.773)
0.862
(0.666 to 1.115)
0.983
(0.718 to 1.346)
Time Frame First dose date up to last dose date (Maximum: 20 days) plus 30 days
Adverse Event Reporting Description The Safety Analysis Set included all randomized participants who took at least 1 dose of study drug. Participants were grouped according to the treatment they actually received.
 
Arm/Group Title Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg All Placebo
Hide Arm/Group Description Participants in fasted state received cilofexor 10 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20. Participants in fasted state received cilofexor 30 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 30 mg tablet, orally, once daily from Day 7 to Day 20. Participants in fasted state received cilofexor 100 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily from Day 7 to Day 20. Participants in fasted state received cilofexor 300 mg tablet, orally, once on Day 1 followed by a 5-day washout period then received cilofexor 300 mg tablet, orally, once daily from Day 7 to Day 20. Participants in fed state received cilofexor 100 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 100 mg tablet, orally, once daily with food from Day 7 to Day 20. Participants in fed state received cilofexor 50 mg tablet, orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 50 mg tablet, orally, twice daily from Day 7 to Day 20. Participants in fed state received cilofexor 15 mg tablet orally, twice with food on Day 1 followed by a 5-day washout period then received cilofexor 15 mg tablet orally, twice daily from Day 7 to Day 20. Participants in fed state received cilofexor 10 mg tablet, orally, once with food on Day 1 followed by a 5-day washout period then received cilofexor 10 mg tablet, orally, once daily from Day 7 to Day 20. Participants in fasted state (cohorts 1-4) and fed state (cohorts 5-8) received placebo tablet(s), orally, once or twice on Day 1 followed by a 5-day washout period then received placebo tablet(s), orally, once or twice daily from Day 7 to Day 20.
All-Cause Mortality
Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg All Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/11 (0.00%)   0/12 (0.00%)   0/11 (0.00%)   0/24 (0.00%) 
Hide Serious Adverse Events
Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg All Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%)   0/11 (0.00%)   0/12 (0.00%)   0/11 (0.00%)   0/24 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1: Cilofexor 10 mg Cohort 2: Cilofexor 30 mg Cohort 3: Cilofexor 100 mg Cohort 4: Cilofexor 300 mg Cohort 5: Cilofexor 100 mg Cohort 6: Cilofexor 50 mg Cohort 7: Cilofexor 15 mg Cohort 8: Cilofexor 10 mg All Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/12 (33.33%)   3/12 (25.00%)   4/12 (33.33%)   3/12 (25.00%)   5/12 (41.67%)   3/11 (27.27%)   9/12 (75.00%)   2/11 (18.18%)   6/24 (25.00%) 
Blood and lymphatic system disorders                   
Anaemia  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  2/12 (16.67%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/24 (0.00%) 
Iron deficiency anaemia  1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/24 (4.17%) 
Eye disorders                   
Ocular discomfort  1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/24 (0.00%) 
Gastrointestinal disorders                   
Abdominal pain  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/24 (0.00%) 
Constipation  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/24 (0.00%) 
Diarrhoea  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  2/12 (16.67%)  0/11 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/24 (0.00%) 
Dyspepsia  1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/24 (0.00%) 
Gastritis  1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/24 (0.00%) 
Nausea  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/24 (0.00%) 
Toothache  1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/24 (0.00%) 
Vomiting  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/24 (0.00%) 
Immune system disorders                   
Hypersensitivity  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/24 (0.00%) 
Infections and infestations                   
Conjunctivitis  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/24 (0.00%) 
Oral herpes  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/24 (0.00%) 
Rhinitis  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/24 (0.00%) 
Viral infection  1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  1/24 (4.17%) 
Viral upper respiratory tract infection  1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/24 (0.00%) 
Injury, poisoning and procedural complications                   
Muscle injury  1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/24 (4.17%) 
Investigations                   
Transaminases increased  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/24 (0.00%) 
Metabolism and nutrition disorders                   
Diabetes mellitus  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Back pain  1  1/12 (8.33%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%)  1/11 (9.09%)  0/12 (0.00%)  0/11 (0.00%)  0/24 (0.00%) 
Muscle spasms  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/24 (0.00%) 
Tendonitis  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/24 (0.00%) 
Nervous system disorders                   
Dizziness  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/24 (0.00%) 
Headache  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  2/12 (16.67%)  1/11 (9.09%)  5/12 (41.67%)  0/11 (0.00%)  3/24 (12.50%) 
Presyncope  1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/24 (0.00%) 
Sciatica  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  0/24 (0.00%) 
Renal and urinary disorders                   
Dysuria  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/24 (0.00%) 
Reproductive system and breast disorders                   
Dysfunctional uterine bleeding  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/24 (0.00%) 
Menorrhagia  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/24 (4.17%) 
Vaginal discharge  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/24 (0.00%) 
Skin and subcutaneous tissue disorders                   
Dermatitis  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/24 (4.17%) 
Dermatitis contact  1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  2/24 (8.33%) 
Ecchymosis  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/11 (9.09%)  0/12 (0.00%)  0/11 (0.00%)  0/24 (0.00%) 
Pruritus generalised  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/24 (0.00%) 
Rash  1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/11 (0.00%)  0/12 (0.00%)  0/11 (0.00%)  0/24 (0.00%) 
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
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Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Publications:
Djedjos CS, Kirby BJ, Billin A, Gosink J, Song Q, Srihari R, et al. Pharmacodynamic Effects of the Oral, Non-Steroidal Farnesoid X Receptor Agonist GS-9674 in Healthy Volunteers. The 67th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting (AASLD); 2016 November 11-15; Boston MA United States.
Kirby BJ, Djedjos CS, Birkeback J, Song Q, Grycz K, Weston J, et al. Evaluation of the Safety and Pharmacokinetics of the Oral, Nonsteroidal Farnesoid X Receptor Agonist GS-9674 in Healthy Volunteers. The 67th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting (AASLD); 2016 November 11-15; Boston MA United States.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02654002    
Other Study ID Numbers: GS-US-402-1851
First Submitted: January 11, 2016
First Posted: January 13, 2016
Results First Submitted: September 16, 2020
Results First Posted: October 12, 2020
Last Update Posted: October 12, 2020