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Effect of Rifabutin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03149848
Recruitment Status : Completed
First Posted : May 11, 2017
Results First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infection, Human Immunodeficiency Virus
Interventions Drug: Cabotegravir
Drug: Rifabutin
Enrollment 15
Recruitment Details A total of 15 participants were enrolled from one center in the United Kingdom. The study was conducted from 06 June 2017 to 07 September 2017.
Pre-assignment Details A total of 26 participants were screened for the study. Of these, 6 participants did not meet the inclusion/exclusion criteria and 5 participants (reserved participants) were eligible however they did not participate in the study. Therefore, 15 participants were enrolled and received at least one dose of study medication.
Arm/Group Title CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
Hide Arm/Group Description Eligible participants received cabotegravir (CAB) 30 milligrams (mg) oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and rifabutin (RBT) 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Period Title: Period 1 (Day 1 to Day 14)
Started 15
Completed 14
Not Completed 1
Reason Not Completed
Protocol-Defined Stopping criteria             1
Period Title: Period 2 (Day 15 to Day 28)
Started 14
Completed 12
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
Hide Arm/Group Description Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
43.7  (10.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
0
   0.0%
Male
15
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Asian - Central/South Asian Heritage
1
   6.7%
White - White/Caucasian/European
14
  93.3%
1.Primary Outcome
Title Assessment of Plasma CAB Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve Over One Dosing Interval (AUC [0 to Tau])
Hide Description Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. AUC (0 to tau) was calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. PK Summary Population included participants who had CAB PK parameter estimates from both serial PK sampling time periods 1 and 2. Comparisons were made for the repeated dose PK parameters of CAB when given alone in Period 1 and when co-administered with steady-state RBT in Period 2.
Time Frame Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population
Arm/Group Title CAB 30 mg RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
Eligible participants received RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram * hour per milliliter
103.978
(28.3%)
81.715
(29.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CAB 30 mg, RBT 300 mg + CAB 30 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.786
Confidence Interval (2-Sided) 90%
0.743 to 0.831
Estimation Comments [Not Specified]
2.Primary Outcome
Title Assessment of Plasma CAB PK Parameter: Maximum Observed Concentration (Cmax)
Hide Description Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Cmax was determined directly from the concentration-time data. Comparisons were made for the repeated dose PK parameters of CAB when given alone in Period 1 and when co-administered with steady-state RBT in Period 2.
Time Frame Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population
Arm/Group Title CAB 30 mg RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
Eligible participants received RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
6.356
(24.7%)
5.246
(24.3%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CAB 30 mg, RBT 300 mg + CAB 30 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.825
Confidence Interval (2-Sided) 90%
0.761 to 0.895
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Assessment of Plasma CAB PK Parameter: Concentration at the End of the Dosing Interval (Ctau)
Hide Description Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Comparisons were made for the repeated dose PK parameters of CAB when given alone in Period 1 and when co-administered with steady-state RBT in Period 2.
Time Frame Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population
Arm/Group Title CAB 30 mg RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
Eligible participants received RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
3.359
(34.3%)
2.479
(36.3%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CAB 30 mg, RBT 300 mg + CAB 30 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.738
Confidence Interval (2-Sided) 90%
0.702 to 0.776
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Assessment of Plasma CAB PK Parameter: Time of Occurrence of Cmax (Tmax)
Hide Description Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Tmax was determined directly from the concentration-time data.
Time Frame Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population
Arm/Group Title CAB 30 mg RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
Eligible participants received RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 12 12
Median (Full Range)
Unit of Measure: Hours
3.000
(1.00 to 4.00)
2.500
(1.00 to 4.00)
5.Secondary Outcome
Title Assessment of Plasma CAB PK Parameter: Terminal Phase Half-life (t1/2)
Hide Description Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Apparent terminal half-life was calculated as: t1/2 = ln2 / Lambda_z, where Lambda_z is the terminal phase rate constant. Plasma t1/2 was not estimated for either period due to limited PK sampling in the terminal phase.
Time Frame Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population. Plasma t1/2 was not estimated for either period due to limited PK sampling in the terminal phase.
Arm/Group Title CAB 30 mg RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
Eligible participants received RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Assessment of Plasma CAB PK Parameter: The Apparent Oral Clearance (CL/F)
Hide Description Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. CL/F was calculated as CL/F =Dose/AUC(0 to tau).
Time Frame Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PK Summary Population
Arm/Group Title CAB 30 mg RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
Eligible participants received RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liters per hour
0.289
(28.3%)
0.367
(29.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CAB 30 mg, RBT 300 mg + CAB 30 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.272
Confidence Interval (2-Sided) 90%
1.204 to 1.345
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect and associated with liver injury and impaired liver function. Safety Population comprised of all participants who enrolled in the study and received at least one dose of study drug.
Time Frame Up to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
Eligible participants received RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15 14
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
1
   6.7%
7
  50.0%
Any SAEs
0
   0.0%
1
   7.1%
8.Secondary Outcome
Title Concurrent Medication Assessment in Treatment Period 1 and 2
Hide Description Concurrent medications included paracetamol and ibuprofen. Number of participants who took concurrent medications during the study are presented.
Time Frame Up to 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
Eligible participants received RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15 14
Measure Type: Count of Participants
Unit of Measure: Participants
Paracetamol
0
   0.0%
3
  21.4%
Ibuprofen
0
   0.0%
1
   7.1%
9.Secondary Outcome
Title Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Hide Description Blood samples for hematology assessment were collected for basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: 10^9 cells/Liter
Basophils, Day -1, n=15 Number Analyzed 15 participants
0.025  (0.0119)
Basophils, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
0.031  (0.0141)
Basophils, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
0.028  (0.0124)
Basophils, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
0.018  (0.0106)
Basophils, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
0.030 [1]   (NA)
Basophils, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
0.010 [1]   (NA)
Basophils, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
0.010 [1]   (NA)
Basophils, Follow-up, n=15 Number Analyzed 15 participants
0.023  (0.0098)
Eosinophils, On-treatment, Day -1, n=15 Number Analyzed 15 participants
0.259  (0.2001)
Eosinophils, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
0.285  (0.2264)
Eosinophils, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
0.315  (0.2306)
Eosinophils, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
0.219  (0.2815)
Eosinophils, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
0.370 [1]   (NA)
Eosinophils, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
0.010 [1]   (NA)
Eosinophils, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
0.120 [1]   (NA)
Eosinophils, Follow-up, n=15 Number Analyzed 15 participants
0.273  (0.2621)
Lymphocytes, Day -1, n=15 Number Analyzed 15 participants
2.509  (0.7383)
Lymphocytes, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
2.224  (0.6596)
Lymphocytes, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
2.071  (0.8625)
Lymphocytes, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
1.551  (0.6554)
Lymphocytes, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
1.200 [1]   (NA)
Lymphocytes, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
0.310 [1]   (NA)
Lymphocytes, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
0.480 [1]   (NA)
Lymphocytes, Follow-up, n=15 Number Analyzed 15 participants
2.140  (0.7373)
Monocytes, Day -1, n=15 Number Analyzed 15 participants
0.561  (0.1570)
Monocytes, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
0.548  (0.1397)
Monocytes, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
0.628  (0.1579)
Monocytes, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
0.488  (0.1442)
Monocytes, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
0.360 [1]   (NA)
Monocytes, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
0.480 [1]   (NA)
Monocytes, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
0.790 [1]   (NA)
Monocytes, Follow-up, n=15 Number Analyzed 15 participants
0.545  (0.1503)
Neutrophils, Day -1, n=15 Number Analyzed 15 participants
4.279  (1.2269)
Neutrophils, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
3.306  (0.9964)
Neutrophils, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
2.818  (1.0823)
Neutrophils, On-treatment, Period 2 Day 21, n=12 Number Analyzed 12 participants
1.979  (0.6006)
Neutrophils, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
2.340 [1]   (NA)
Neutrophils, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
3.830 [1]   (NA)
Neutrophils, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
3.970 [1]   (NA)
Neutrophils, Follow-up, n=15 Number Analyzed 15 participants
2.840  (0.8665)
Platelets, Day -1, n=15 Number Analyzed 15 participants
234.7  (34.58)
Platelets, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
210.7  (31.46)
Platelets, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
214.5  (31.04)
Platelets, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
193.9  (34.47)
Platelets, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
206.0 [1]   (NA)
Platelets, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
206.0 [1]   (NA)
Platelets, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
169.0 [1]   (NA)
Platelets, Follow-up, n=15 Number Analyzed 15 participants
229.8  (45.57)
Leukocytes, Day -1, n=15 Number Analyzed 15 participants
7.633  (1.6572)
Leukocytes, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
6.394  (1.5268)
Leukocytes, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
5.859  (1.5835)
Leukocytes, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
4.256  (1.3035)
Leukocytes, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
4.300 [1]   (NA)
Leukocytes, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
4.640 [1]   (NA)
Leukocytes, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
5.370 [1]   (NA)
Leukocytes, Follow-up, n=15 Number Analyzed 15 participants
5.822  (1.3583)
[1]
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
10.Secondary Outcome
Title Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
Hide Description Blood samples for hematology assessment were collected for Hematocrit and R/E. NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Proportion of red blood cells in blood
Hematocrit, Day -1, n=15 Number Analyzed 15 participants
0.411  (0.02107)
Hematocrit, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
0.427  (0.02432)
Hematocrit, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
0.415  (0.02277)
Hematocrit, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
0.425  (0.02139)
Hematocrit, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
0.413 [1]   (NA)
Hematocrit, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
0.419 [1]   (NA)
Hematocrit, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
0.412 [1]   (NA)
Hematocrit, Follow-up, n=15 Number Analyzed 15 participants
0.411  (0.01766)
R/E, Day -1, n=15 Number Analyzed 15 participants
0.008  (0.00228)
R/E, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
0.008  (0.00248)
R/E, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
0.008  (0.00209)
R/E, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
0.006  (0.00219)
R/E, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
0.013 [1]   (NA)
R/E, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
0.009 [1]   (NA)
R/E, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
0.003 [1]   (NA)
R/E, Follow-up, n=15 Number Analyzed 15 participants
0.010  (0.00270)
[1]
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
11.Secondary Outcome
Title Assessment of Hematology Parameter: Hemoglobin
Hide Description Blood samples for hematology assessment was collected for Hemoglobin. NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Grams per Liter
Day -1, n=15 Number Analyzed 15 participants
144.7  (7.25)
Period 1 Day 13, n=14 Number Analyzed 14 participants
143.5  (7.51)
Period 2 Day 21, n=13 Number Analyzed 13 participants
146.4  (8.13)
Period 2 Day 27, n=12 Number Analyzed 12 participants
144.2  (9.93)
Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
137.0 [1]   (NA)
Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
147.0 [1]   (NA)
Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
146.0 [1]   (NA)
Follow-up, n=15 Number Analyzed 15 participants
140.1  (6.04)
[1]
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
12.Secondary Outcome
Title Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin
Hide Description Blood samples for hematology assessment was collected for Eryrocyte Mean Corpuscular Hemoglobin. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Picograms
Day -1, n=15 Number Analyzed 15 participants
29.77  (1.457)
On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
29.54  (1.536)
On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
30.13  (1.329)
On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
29.74  (1.466)
Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
29.30 [1]   (NA)
Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
27.80 [1]   (NA)
Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
30.90 [1]   (NA)
Follow-up, n=15 Number Analyzed 15 participants
29.49  (1.451)
[1]
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
13.Secondary Outcome
Title Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume
Hide Description Blood samples for hematology assessment was collected for Erythrocyte Mean Corpuscular Volume. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Femtoliters
Day -1, n=15 Number Analyzed 15 participants
84.60  (3.522)
On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
87.94  (2.829)
On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
85.39  (3.367)
On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
87.73  (3.997)
Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
88.20 [1]   (NA)
Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
79.20 [1]   (NA)
Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
87.10 [1]   (NA)
Follow-up, n=15 Number Analyzed 15 participants
86.59  (3.618)
[1]
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
14.Secondary Outcome
Title Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Hide Description Blood samples for hematology assessment were collected for Erythrocytes and reticulocytes. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: 10^12 cells/Liter
Erythrocytes, Day -1, n=15 Number Analyzed 15 participants
4.870  (0.3068)
Erythrocytes, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
4.869  (0.3400)
Erythrocytes, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
4.868  (0.3173)
Erythrocytes, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
4.855  (0.3605)
Erythrocytes, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
4.680 [1]   (NA)
Erythrocytes, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
5.290 [1]   (NA)
Erythrocytes, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
4.730 [1]   (NA)
Erythrocytes, Follow-up, n=15 Number Analyzed 15 participants
4.761  (0.3372)
Reticulocytes, Day -1, n=15 Number Analyzed 15 participants
0.043  (0.01246)
Reticulocytes, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
0.040  (0.01350)
Reticulocytes, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
0.040  (0.01097)
Reticulocytes, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
0.028  (0.00997)
Reticulocytes, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
0.064 [1]   (NA)
Reticulocytes, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
0.051 [1]   (NA)
Reticulocytes, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
0.014 [1]   (NA)
Reticulocytes, Follow-up, n=15 Number Analyzed 15 participants
0.049  (0.01415)
[1]
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
15.Secondary Outcome
Title Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW)
Hide Description Blood samples for hematology assessment was collected for EDW. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Percentage of EDW
Day -1, n=15 Number Analyzed 15 participants
12.91  (0.513)
On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
13.13  (0.595)
On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
12.89  (0.641)
On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
12.90  (0.624)
Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
13.40 [1]   (NA)
Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
13.60 [1]   (NA)
Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
12.40 [1]   (NA)
Follow-up, n=15 Number Analyzed 15 participants
12.90  (0.535)
[1]
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
16.Secondary Outcome
Title Assessment of Clinical Chemistry Parameters: Albumin and Protein
Hide Description Samples for clinical chemistry assessment were collected for Albumin and Protein. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Grams per Liter
Albumin, Day -1, n=15 Number Analyzed 15 participants
45.2  (1.90)
Albumin, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
44.2  (2.58)
Albumin, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
43.4  (2.06)
Albumin, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
43.7  (1.87)
Albumin, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
38.0 [1]   (NA)
Albumin, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
44.0 [1]   (NA)
Albumin, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
42.0 [1]   (NA)
Albumin, Follow-up, n=15 Number Analyzed 15 participants
42.7  (1.59)
Protein, Day -1, n=15 Number Analyzed 15 participants
67.9  (3.98)
Protein, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
67.3  (3.22)
Protein, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
65.1  (3.82)
Protein, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
65.8  (4.00)
Protein, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
60.0 [1]   (NA)
Protein, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
63.0 [1]   (NA)
Protein, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
70.0 [1]   (NA)
Protein, Follow-up, n=15 Number Analyzed 15 participants
63.7  (2.55)
[1]
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
17.Secondary Outcome
Title Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
Hide Description Samples for clinical chemistry assessment were collected for ALP, AST, ALT, CK and GGT. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: International units per Liter
ALP, Day -1, n=15 Number Analyzed 15 participants
62.7  (14.52)
ALP, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
60.1  (14.34)
ALP, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
60.7  (13.94)
ALP, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
59.9  (17.83)
ALP, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
51.0 [1]   (NA)
ALP, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
61.0 [1]   (NA)
ALP, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
56.0 [1]   (NA)
ALP, Follow-up, n=15 Number Analyzed 15 participants
60.7  (13.35)
ALT, Day -1, n=15 Number Analyzed 15 participants
23.5  (7.07)
ALT, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
25.5  (8.83)
ALT, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
30.2  (20.12)
ALT, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
30.8  (29.65)
ALT, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
155.0 [1]   (NA)
ALT, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
39.0 [1]   (NA)
ALT, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
34.0 [1]   (NA)
ALT, Follow-up, n=15 Number Analyzed 15 participants
37.3  (23.40)
AST, Day -1, n=15 Number Analyzed 15 participants
18.5  (3.62)
AST, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
20.7  (6.85)
AST, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
20.9  (5.87)
AST, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
23.3  (11.48)
AST, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
83.0 [1]   (NA)
AST, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
26.0 [1]   (NA)
AST, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
37.0 [1]   (NA)
AST, Follow-up, n=15 Number Analyzed 15 participants
24.9  (9.44)
CK, Day -1, n=15 Number Analyzed 15 participants
133.6  (40.31)
CK, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
227.1  (303.97)
CK, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
104.2  (43.44)
CK, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
88.7  (42.09)
CK, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
1278.0 [1]   (NA)
CK, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
177.0 [1]   (NA)
CK, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
164.0 [1]   (NA)
CK, Follow-up, n=15 Number Analyzed 15 participants
144.3  (80.81)
GGT, Day -1, n=15 Number Analyzed 15 participants
25.5  (14.97)
GGT, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
22.6  (13.20)
GGT, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
26.8  (23.95)
GGT, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
28.1  (28.25)
GGT, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
17.0 [1]   (NA)
GGT, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
36.0 [1]   (NA)
GGT, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
82.0 [1]   (NA)
GGT, Follow-up, n=15 Number Analyzed 15 participants
36.1  (33.77)
[1]
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
18.Secondary Outcome
Title Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Hide Description Samples for clinical chemistry assessment were collected for DB, bilirubin and creatinine. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Micromoles per Liter
DB, Day -1, n=15 Number Analyzed 15 participants
3.5  (2.00)
DB, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
3.5  (1.83)
DB, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
2.4  (1.45)
DB, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
2.2  (1.19)
DB, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
4.0 [1]   (NA)
DB, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
1.0 [1]   (NA)
DB, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
2.0 [1]   (NA)
DB, Follow-up, n=15 Number Analyzed 15 participants
2.9  (1.39)
Bilirubin, Day -1, n=15 Number Analyzed 15 participants
9.8  (6.72)
Bilirubin, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
10.1  (5.83)
Bilirubin, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
6.6  (4.74)
Bilirubin, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
5.3  (2.99)
Bilirubin, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
10.0 [1]   (NA)
Bilirubin, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
3.0 [1]   (NA)
Bilirubin, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
5.0 [1]   (NA)
Bilirubin, Follow-up, n=15 Number Analyzed 15 participants
7.9  (3.83)
Creatinine, Day -1, n=15 Number Analyzed 15 participants
83.1  (7.71)
Creatinine, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
85.9  (11.02)
Creatinine, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
88.4  (9.43)
Creatinine, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
83.8  (10.69)
Creatinine, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
64.0 [1]   (NA)
Creatinine, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
71.0 [1]   (NA)
Creatinine, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
91.0 [1]   (NA)
Creatinine, Follow-up, n=15 Number Analyzed 15 participants
80.7  (9.65)
[1]
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
19.Secondary Outcome
Title Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Hide Description Samples for clinical chemistry assessment were collected for Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Millimoles per Liter
Calcium, Day -1, n=15 Number Analyzed 15 participants
2.31  (0.0539)
Calcium, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
2.34  (0.0770)
Calcium, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
2.29  (0.0720)
Calcium, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
2.28  (0.0844)
Calcium, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
2.27 [1]   (NA)
Calcium, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
2.38 [1]   (NA)
Calcium, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
2.06 [1]   (NA)
Calcium, Follow-up, n=15 Number Analyzed 15 participants
2.28  (0.0400)
Chloride, Day -1, n=15 Number Analyzed 15 participants
101.0  (1.73)
Chloride, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
100.5  (1.45)
Chloride, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
101.1  (2.40)
Chloride, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
101.8  (2.14)
Chloride, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
101.0 [1]   (NA)
Chloride, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
100.0 [1]   (NA)
Chloride, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
99.0 [1]   (NA)
Chloride, Follow-up, n=15 Number Analyzed 15 participants
102.5  (2.07)
Carbon Dioxide, Day -1, n=15 Number Analyzed 15 participants
25.6  (1.12)
Carbon Dioxide, On-treatment, Period 1 Day13, n=14 Number Analyzed 14 participants
25.3  (1.38)
Carbon Dioxide, On-treatment, Period 2 Day21, n=13 Number Analyzed 13 participants
27.4  (2.10)
Carbon Dioxide, On-treatment, Period 2 Day27, n=12 Number Analyzed 12 participants
24.7  (3.11)
Carbon Dioxide, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
25.0 [1]   (NA)
Carbon Dioxide, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
27.0 [1]   (NA)
Carbon Dioxide, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
20.0 [1]   (NA)
Carbon Dioxide, Follow-up, n=15 Number Analyzed 15 participants
25.7  (1.76)
Glucose, Day -1, n=15 Number Analyzed 15 participants
5.27  (1.077)
Glucose, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
5.51  (0.487)
Glucose, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
5.45  (0.399)
Glucose, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
5.95  (1.103)
Glucose, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
5.00 [1]   (NA)
Glucose, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
5.40 [1]   (NA)
Glucose, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
6.00 [1]   (NA)
Glucose, Follow-up, n=15 Number Analyzed 15 participants
5.35  (0.374)
Potassium, Day -1, n=15 Number Analyzed 15 participants
4.22  (0.166)
Potassium, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
4.29  (0.250)
Potassium, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
4.36  (0.386)
Potassium, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
4.29  (0.247)
Potassium, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
3.90 [1]   (NA)
Potassium, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
4.00 [1]   (NA)
Potassium, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
4.10 [1]   (NA)
Potassium, Follow-up, n=15 Number Analyzed 15 participants
4.31  (0.183)
Sodium, Day -1, n=15 Number Analyzed 15 participants
141.1  (1.28)
Sodium, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
139.6  (1.82)
Sodium, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
140.3  (2.36)
Sodium, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
139.8  (2.09)
Sodium, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
139.0 [1]   (NA)
Sodium, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
140.0 [1]   (NA)
Sodium, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
137.0 [1]   (NA)
Sodium, Follow-up, n=15 Number Analyzed 15 participants
141.1  (2.02)
Urea, Day -1, n=15 Number Analyzed 15 participants
5.73  (1.4048)
Urea, On-treatment, Period 1 Day 13, n=14 Number Analyzed 14 participants
5.19  (1.0830)
Urea, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
5.69  (1.3678)
Urea, On-treatment, Period 2 Day 27, n=12 Number Analyzed 12 participants
5.18  (1.2104)
Urea, Follow-up, Period 1 Day 13, n=1 Number Analyzed 1 participants
4.69 [1]   (NA)
Urea, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
2.79 [1]   (NA)
Urea, Follow-up, Period 2 Day 27, n=1 Number Analyzed 1 participants
4.09 [1]   (NA)
Urea, Follow-up, n=15 Number Analyzed 15 participants
5.34  (1.2189)
[1]
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
20.Secondary Outcome
Title Number of Participants With Abnormal Urinalysis Result
Hide Description Samples for urinalysis assessment was collected at Day -1, Day 13, Day 21, Day 27 and during follow-up period (10 to 14 daya after last dose). Data for participants with abnormal urinalysis results has been presented.
Time Frame Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)
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Safety Population.
Arm/Group Title CAB 30 mg RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
Eligible participants received RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
21.Secondary Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Hide Description ECG measurements was performed with the participant in a semi-supine position having rested in this position for at least 10 minutes beforehand. Data has been presented for Period 1, Day 14 pre-dose which showed abnormal- not clinically significant ECG finding. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Day 1, 14, 21, 28 and follow-up (10 to 14 days after last dose)
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Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
Eligible participants received RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 14 12
Measure Type: Count of Participants
Unit of Measure: Participants
1
   7.1%
0
   0.0%
22.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Hide Description Vital signs measurement was done in semi-supine position after 10 minutes rest and included SBP and DBP. Two blood pressure measurement were taken at pre-dose on Day 1, at least 1 minute apart. The mean value recorded at pre-dose was classified as Baseline. Single blood pressure was obtained at all other time points during the study. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Baseline to follow-up (10 to 14 days after last dose)
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Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Millimeters of Mercury
SBP, On-treatment, Period 1 Day 14, n=14 Number Analyzed 14 participants
-2.5  (9.17)
SBP, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
1.5  (11.90)
SBP, On-treatment, Period 2 Day 28, n=12 Number Analyzed 12 participants
0.5  (8.74)
SBP, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
17.0 [1]   (NA)
SBP, Follow-up, n=15 Number Analyzed 15 participants
3.7  (12.85)
DBP, On-treatment, Period 1 Day 14, n=14 Number Analyzed 14 participants
0.8  (7.61)
DBP, On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
2.0  (9.10)
DBP, On-treatment, Period 2 Day 28, n=12 Number Analyzed 12 participants
-1.6  (4.21)
DBP, Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
9.5 [1]   (NA)
DBP, Follow-up, n=15 Number Analyzed 15 participants
3.3  (9.04)
[1]
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
23.Secondary Outcome
Title Change From Baseline in Pulse Rate
Hide Description Vital signs measurement was done in semi-supine position after 10 minutes rest and included pulse rate. Two pulse rate measurement were taken at pre-dose on Day 1, at least 1 minute apart. The mean value recorded at pre-dose was classified as Baseline. Single pulse rate was obtained at all other time points during the study. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Baseline to follow-up (10 to 14 days after last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
Hide Arm/Group Description:
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1 and RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: Beats/minute
On-treatment, Period 1 Day 14, n=14 Number Analyzed 14 participants
-4.5  (8.31)
On-treatment, Period 2 Day 21, n=13 Number Analyzed 13 participants
-6.2  (9.98)
On-treatment, Period 2 Day 28, n=12 Number Analyzed 12 participants
3.4  (9.52)
Follow-up, Period 2 Day 21, n=1 Number Analyzed 1 participants
39.0 [1]   (NA)
Follow-up, n=15 Number Analyzed 15 participants
-1.3  (10.58)
[1]
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
Time Frame AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
Adverse Event Reporting Description AEs and SAEs were collected for the Safety Population which comprised of all participants who enrolled in the study and received at least one dose of study drug was included in the Safety Population.
 
Arm/Group Title CAB 30 mg RBT 300 mg + CAB 30 mg
Hide Arm/Group Description Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1. Eligible participants received RBT 300 mg (2x150 mg) oral capsules once daily along with CAB 30 mg oral tablets once daily for 14 days (Day 15 to Day 28) during Period 2.
All-Cause Mortality
CAB 30 mg RBT 300 mg + CAB 30 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
CAB 30 mg RBT 300 mg + CAB 30 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   1/14 (7.14%) 
Investigations     
Alanine aminotransferase increased  1  0/15 (0.00%)  1/14 (7.14%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CAB 30 mg RBT 300 mg + CAB 30 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   1/15 (6.67%)   7/14 (50.00%) 
Blood and lymphatic system disorders     
Leukopenia  1  0/15 (0.00%)  1/14 (7.14%) 
Neutropenia  1  0/15 (0.00%)  1/14 (7.14%) 
General disorders     
Pyrexia  1  0/15 (0.00%)  1/14 (7.14%) 
Infections and infestations     
Viral infection  1  0/15 (0.00%)  1/14 (7.14%) 
Injury, poisoning and procedural complications     
Contusion  1  1/15 (6.67%)  0/14 (0.00%) 
Skin abrasion  1  0/15 (0.00%)  1/14 (7.14%) 
Investigations     
Blood creatine phosphokinase increased  1  1/15 (6.67%)  0/14 (0.00%) 
Body temperature increased  1  0/15 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal stiffness  1  0/15 (0.00%)  1/14 (7.14%) 
Nervous system disorders     
Headache  1  0/15 (0.00%)  1/14 (7.14%) 
Skin and subcutaneous tissue disorders     
Hyperkeratosis  1  0/15 (0.00%)  1/14 (7.14%) 
1
Term from vocabulary, MedDRA 20.1
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT03149848     History of Changes
Other Study ID Numbers: 205712
First Submitted: May 9, 2017
First Posted: May 11, 2017
Results First Submitted: September 4, 2018
Results First Posted: February 4, 2019
Last Update Posted: February 4, 2019