Trial Outcomes & Findings for Effect of Rifabutin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects (NCT NCT03149848)
NCT ID: NCT03149848
Last Updated: 2020-09-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
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
Results posted on
2020-09-17
Participant Flow
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.
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.
Participant milestones
| Measure |
CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
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 1 (Day 1 to Day 14)
STARTED
|
15
|
|
Period 1 (Day 1 to Day 14)
COMPLETED
|
14
|
|
Period 1 (Day 1 to Day 14)
NOT COMPLETED
|
1
|
|
Period 2 (Day 15 to Day 28)
STARTED
|
14
|
|
Period 2 (Day 15 to Day 28)
COMPLETED
|
12
|
|
Period 2 (Day 15 to Day 28)
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
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 1 (Day 1 to Day 14)
Protocol-Defined Stopping criteria
|
1
|
|
Period 2 (Day 15 to Day 28)
Adverse Event
|
2
|
Baseline Characteristics
Effect of Rifabutin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects
Baseline characteristics by cohort
| Measure |
CAB 30 mg Followed by RBT 300 mg + CAB 30 mg
n=15 Participants
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.
|
|---|---|
|
Age, Continuous
|
43.7 Years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 28Population: PK Summary Population
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.
Outcome measures
| Measure |
CAB 30 mg
n=12 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
n=12 Participants
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.
|
|---|---|---|
|
Assessment of Plasma CAB Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve Over One Dosing Interval (AUC [0 to Tau])
|
103.978 Microgram * hour per milliliter
Geometric Coefficient of Variation 28.3
|
81.715 Microgram * hour per milliliter
Geometric Coefficient of Variation 29.9
|
PRIMARY outcome
Timeframe: 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 28Population: PK Summary Population
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.
Outcome measures
| Measure |
CAB 30 mg
n=12 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
n=12 Participants
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.
|
|---|---|---|
|
Assessment of Plasma CAB PK Parameter: Maximum Observed Concentration (Cmax)
|
6.356 Micrograms per milliliter
Geometric Coefficient of Variation 24.7
|
5.246 Micrograms per milliliter
Geometric Coefficient of Variation 24.3
|
SECONDARY outcome
Timeframe: 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 28Population: PK Summary Population
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.
Outcome measures
| Measure |
CAB 30 mg
n=12 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
n=12 Participants
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.
|
|---|---|---|
|
Assessment of Plasma CAB PK Parameter: Concentration at the End of the Dosing Interval (Ctau)
|
3.359 Micrograms per milliliter
Geometric Coefficient of Variation 34.3
|
2.479 Micrograms per milliliter
Geometric Coefficient of Variation 36.3
|
SECONDARY outcome
Timeframe: 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 28Population: PK Summary Population
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.
Outcome measures
| Measure |
CAB 30 mg
n=12 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
n=12 Participants
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.
|
|---|---|---|
|
Assessment of Plasma CAB PK Parameter: Time of Occurrence of Cmax (Tmax)
|
3.000 Hours
Interval 1.0 to 4.0
|
2.500 Hours
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: 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 28Population: PK Summary Population. Plasma t1/2 was not estimated for either period due to limited PK sampling in the terminal phase.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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 28Population: PK Summary Population
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).
Outcome measures
| Measure |
CAB 30 mg
n=12 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
n=12 Participants
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.
|
|---|---|---|
|
Assessment of Plasma CAB PK Parameter: The Apparent Oral Clearance (CL/F)
|
0.289 Liters per hour
Geometric Coefficient of Variation 28.3
|
0.367 Liters per hour
Geometric Coefficient of Variation 29.9
|
SECONDARY outcome
Timeframe: Up to 10 weeksPopulation: Safety Population.
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.
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
n=14 Participants
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.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AEs
|
1 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAEs
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 10 weeksPopulation: Safety Population.
Concurrent medications included paracetamol and ibuprofen. Number of participants who took concurrent medications during the study are presented.
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
n=14 Participants
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.
|
|---|---|---|
|
Concurrent Medication Assessment in Treatment Period 1 and 2
Paracetamol
|
0 Participants
|
3 Participants
|
|
Concurrent Medication Assessment in Treatment Period 1 and 2
Ibuprofen
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)Population: Safety Population.
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).
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
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.
|
|---|---|---|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils, Day -1, n=15
|
0.025 10^9 cells/Liter
Standard Deviation 0.0119
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils, On-treatment, Period 1 Day 13, n=14
|
0.031 10^9 cells/Liter
Standard Deviation 0.0141
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils, On-treatment, Period 2 Day 21, n=13
|
0.028 10^9 cells/Liter
Standard Deviation 0.0124
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils, On-treatment, Period 2 Day 27, n=12
|
0.018 10^9 cells/Liter
Standard Deviation 0.0106
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils, Follow-up, Period 1 Day 13, n=1
|
0.030 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils, Follow-up, Period 2 Day 21, n=1
|
0.010 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils, Follow-up, Period 2 Day 27, n=1
|
0.010 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Basophils, Follow-up, n=15
|
0.023 10^9 cells/Liter
Standard Deviation 0.0098
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils, On-treatment, Day -1, n=15
|
0.259 10^9 cells/Liter
Standard Deviation 0.2001
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils, On-treatment, Period 1 Day 13, n=14
|
0.285 10^9 cells/Liter
Standard Deviation 0.2264
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils, On-treatment, Period 2 Day 21, n=13
|
0.315 10^9 cells/Liter
Standard Deviation 0.2306
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils, On-treatment, Period 2 Day 27, n=12
|
0.219 10^9 cells/Liter
Standard Deviation 0.2815
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils, Follow-up, Period 1 Day 13, n=1
|
0.370 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils, Follow-up, Period 2 Day 21, n=1
|
0.010 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils, Follow-up, Period 2 Day 27, n=1
|
0.120 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Eosinophils, Follow-up, n=15
|
0.273 10^9 cells/Liter
Standard Deviation 0.2621
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes, Day -1, n=15
|
2.509 10^9 cells/Liter
Standard Deviation 0.7383
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes, On-treatment, Period 1 Day 13, n=14
|
2.224 10^9 cells/Liter
Standard Deviation 0.6596
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes, On-treatment, Period 2 Day 21, n=13
|
2.071 10^9 cells/Liter
Standard Deviation 0.8625
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes, On-treatment, Period 2 Day 27, n=12
|
1.551 10^9 cells/Liter
Standard Deviation 0.6554
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes, Follow-up, Period 1 Day 13, n=1
|
1.200 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes, Follow-up, Period 2 Day 21, n=1
|
0.310 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes, Follow-up, Period 2 Day 27, n=1
|
0.480 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Lymphocytes, Follow-up, n=15
|
2.140 10^9 cells/Liter
Standard Deviation 0.7373
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes, Day -1, n=15
|
0.561 10^9 cells/Liter
Standard Deviation 0.1570
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes, On-treatment, Period 1 Day 13, n=14
|
0.548 10^9 cells/Liter
Standard Deviation 0.1397
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes, On-treatment, Period 2 Day 21, n=13
|
0.628 10^9 cells/Liter
Standard Deviation 0.1579
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes, On-treatment, Period 2 Day 27, n=12
|
0.488 10^9 cells/Liter
Standard Deviation 0.1442
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes, Follow-up, Period 1 Day 13, n=1
|
0.360 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes, Follow-up, Period 2 Day 21, n=1
|
0.480 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes, Follow-up, Period 2 Day 27, n=1
|
0.790 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Monocytes, Follow-up, n=15
|
0.545 10^9 cells/Liter
Standard Deviation 0.1503
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, Day -1, n=15
|
4.279 10^9 cells/Liter
Standard Deviation 1.2269
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, On-treatment, Period 1 Day 13, n=14
|
3.306 10^9 cells/Liter
Standard Deviation 0.9964
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, On-treatment, Period 2 Day 21, n=13
|
2.818 10^9 cells/Liter
Standard Deviation 1.0823
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, On-treatment, Period 2 Day 21, n=12
|
1.979 10^9 cells/Liter
Standard Deviation 0.6006
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, Follow-up, Period 1 Day 13, n=1
|
2.340 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, Follow-up, Period 2 Day 21, n=1
|
3.830 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, Follow-up, Period 2 Day 27, n=1
|
3.970 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Neutrophils, Follow-up, n=15
|
2.840 10^9 cells/Liter
Standard Deviation 0.8665
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Day -1, n=15
|
234.7 10^9 cells/Liter
Standard Deviation 34.58
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, On-treatment, Period 1 Day 13, n=14
|
210.7 10^9 cells/Liter
Standard Deviation 31.46
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, On-treatment, Period 2 Day 21, n=13
|
214.5 10^9 cells/Liter
Standard Deviation 31.04
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, On-treatment, Period 2 Day 27, n=12
|
193.9 10^9 cells/Liter
Standard Deviation 34.47
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Follow-up, Period 1 Day 13, n=1
|
206.0 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Follow-up, Period 2 Day 21, n=1
|
206.0 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Follow-up, Period 2 Day 27, n=1
|
169.0 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Platelets, Follow-up, n=15
|
229.8 10^9 cells/Liter
Standard Deviation 45.57
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, Day -1, n=15
|
7.633 10^9 cells/Liter
Standard Deviation 1.6572
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, On-treatment, Period 1 Day 13, n=14
|
6.394 10^9 cells/Liter
Standard Deviation 1.5268
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, On-treatment, Period 2 Day 21, n=13
|
5.859 10^9 cells/Liter
Standard Deviation 1.5835
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, On-treatment, Period 2 Day 27, n=12
|
4.256 10^9 cells/Liter
Standard Deviation 1.3035
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, Follow-up, Period 1 Day 13, n=1
|
4.300 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, Follow-up, Period 2 Day 21, n=1
|
4.640 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, Follow-up, Period 2 Day 27, n=1
|
5.370 10^9 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
Leukocytes, Follow-up, n=15
|
5.822 10^9 cells/Liter
Standard Deviation 1.3583
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)Population: Safety Population.
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).
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
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.
|
|---|---|---|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
Hematocrit, Day -1, n=15
|
0.411 Proportion of red blood cells in blood
Standard Deviation 0.02107
|
—
|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
Hematocrit, On-treatment, Period 1 Day 13, n=14
|
0.427 Proportion of red blood cells in blood
Standard Deviation 0.02432
|
—
|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
Hematocrit, On-treatment, Period 2 Day 21, n=13
|
0.415 Proportion of red blood cells in blood
Standard Deviation 0.02277
|
—
|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
Hematocrit, On-treatment, Period 2 Day 27, n=12
|
0.425 Proportion of red blood cells in blood
Standard Deviation 0.02139
|
—
|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
Hematocrit, Follow-up, Period 1 Day 13, n=1
|
0.413 Proportion of red blood cells in blood
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
Hematocrit, Follow-up, Period 2 Day 21, n=1
|
0.419 Proportion of red blood cells in blood
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
Hematocrit, Follow-up, Period 2 Day 27, n=1
|
0.412 Proportion of red blood cells in blood
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
Hematocrit, Follow-up, n=15
|
0.411 Proportion of red blood cells in blood
Standard Deviation 0.01766
|
—
|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
R/E, Day -1, n=15
|
0.008 Proportion of red blood cells in blood
Standard Deviation 0.00228
|
—
|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
R/E, On-treatment, Period 1 Day 13, n=14
|
0.008 Proportion of red blood cells in blood
Standard Deviation 0.00248
|
—
|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
R/E, On-treatment, Period 2 Day 21, n=13
|
0.008 Proportion of red blood cells in blood
Standard Deviation 0.00209
|
—
|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
R/E, On-treatment, Period 2 Day 27, n=12
|
0.006 Proportion of red blood cells in blood
Standard Deviation 0.00219
|
—
|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
R/E, Follow-up, Period 1 Day 13, n=1
|
0.013 Proportion of red blood cells in blood
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
R/E, Follow-up, Period 2 Day 21, n=1
|
0.009 Proportion of red blood cells in blood
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
R/E, Follow-up, Period 2 Day 27, n=1
|
0.003 Proportion of red blood cells in blood
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)
R/E, Follow-up, n=15
|
0.010 Proportion of red blood cells in blood
Standard Deviation 0.00270
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)Population: Safety Population.
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).
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
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.
|
|---|---|---|
|
Assessment of Hematology Parameter: Hemoglobin
Day -1, n=15
|
144.7 Grams per Liter
Standard Deviation 7.25
|
—
|
|
Assessment of Hematology Parameter: Hemoglobin
Period 1 Day 13, n=14
|
143.5 Grams per Liter
Standard Deviation 7.51
|
—
|
|
Assessment of Hematology Parameter: Hemoglobin
Period 2 Day 21, n=13
|
146.4 Grams per Liter
Standard Deviation 8.13
|
—
|
|
Assessment of Hematology Parameter: Hemoglobin
Period 2 Day 27, n=12
|
144.2 Grams per Liter
Standard Deviation 9.93
|
—
|
|
Assessment of Hematology Parameter: Hemoglobin
Follow-up, Period 1 Day 13, n=1
|
137.0 Grams per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameter: Hemoglobin
Follow-up, Period 2 Day 21, n=1
|
147.0 Grams per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameter: Hemoglobin
Follow-up, Period 2 Day 27, n=1
|
146.0 Grams per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameter: Hemoglobin
Follow-up, n=15
|
140.1 Grams per Liter
Standard Deviation 6.04
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)Population: Safety Population.
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).
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
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.
|
|---|---|---|
|
Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin
Day -1, n=15
|
29.77 Picograms
Standard Deviation 1.457
|
—
|
|
Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin
On-treatment, Period 1 Day 13, n=14
|
29.54 Picograms
Standard Deviation 1.536
|
—
|
|
Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin
On-treatment, Period 2 Day 21, n=13
|
30.13 Picograms
Standard Deviation 1.329
|
—
|
|
Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin
On-treatment, Period 2 Day 27, n=12
|
29.74 Picograms
Standard Deviation 1.466
|
—
|
|
Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin
Follow-up, Period 1 Day 13, n=1
|
29.30 Picograms
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin
Follow-up, Period 2 Day 21, n=1
|
27.80 Picograms
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin
Follow-up, Period 2 Day 27, n=1
|
30.90 Picograms
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin
Follow-up, n=15
|
29.49 Picograms
Standard Deviation 1.451
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)Population: Safety Population.
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).
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
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.
|
|---|---|---|
|
Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume
Day -1, n=15
|
84.60 Femtoliters
Standard Deviation 3.522
|
—
|
|
Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume
On-treatment, Period 1 Day 13, n=14
|
87.94 Femtoliters
Standard Deviation 2.829
|
—
|
|
Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume
On-treatment, Period 2 Day 21, n=13
|
85.39 Femtoliters
Standard Deviation 3.367
|
—
|
|
Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume
On-treatment, Period 2 Day 27, n=12
|
87.73 Femtoliters
Standard Deviation 3.997
|
—
|
|
Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume
Follow-up, Period 1 Day 13, n=1
|
88.20 Femtoliters
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume
Follow-up, Period 2 Day 21, n=1
|
79.20 Femtoliters
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume
Follow-up, Period 2 Day 27, n=1
|
87.10 Femtoliters
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume
Follow-up, n=15
|
86.59 Femtoliters
Standard Deviation 3.618
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)Population: Safety Population.
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).
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
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.
|
|---|---|---|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Erythrocytes, Day -1, n=15
|
4.870 10^12 cells/Liter
Standard Deviation 0.3068
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Erythrocytes, On-treatment, Period 1 Day 13, n=14
|
4.869 10^12 cells/Liter
Standard Deviation 0.3400
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Erythrocytes, On-treatment, Period 2 Day 21, n=13
|
4.868 10^12 cells/Liter
Standard Deviation 0.3173
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Erythrocytes, On-treatment, Period 2 Day 27, n=12
|
4.855 10^12 cells/Liter
Standard Deviation 0.3605
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Erythrocytes, Follow-up, Period 1 Day 13, n=1
|
4.680 10^12 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Erythrocytes, Follow-up, Period 2 Day 21, n=1
|
5.290 10^12 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Erythrocytes, Follow-up, Period 2 Day 27, n=1
|
4.730 10^12 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Erythrocytes, Follow-up, n=15
|
4.761 10^12 cells/Liter
Standard Deviation 0.3372
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Reticulocytes, Day -1, n=15
|
0.043 10^12 cells/Liter
Standard Deviation 0.01246
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Reticulocytes, On-treatment, Period 1 Day 13, n=14
|
0.040 10^12 cells/Liter
Standard Deviation 0.01350
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Reticulocytes, On-treatment, Period 2 Day 21, n=13
|
0.040 10^12 cells/Liter
Standard Deviation 0.01097
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Reticulocytes, On-treatment, Period 2 Day 27, n=12
|
0.028 10^12 cells/Liter
Standard Deviation 0.00997
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Reticulocytes, Follow-up, Period 1 Day 13, n=1
|
0.064 10^12 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Reticulocytes, Follow-up, Period 2 Day 21, n=1
|
0.051 10^12 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Reticulocytes, Follow-up, Period 2 Day 27, n=1
|
0.014 10^12 cells/Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes and Reticulocytes
Reticulocytes, Follow-up, n=15
|
0.049 10^12 cells/Liter
Standard Deviation 0.01415
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)Population: Safety Population.
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).
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
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.
|
|---|---|---|
|
Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW)
Day -1, n=15
|
12.91 Percentage of EDW
Standard Deviation 0.513
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW)
On-treatment, Period 1 Day 13, n=14
|
13.13 Percentage of EDW
Standard Deviation 0.595
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW)
On-treatment, Period 2 Day 21, n=13
|
12.89 Percentage of EDW
Standard Deviation 0.641
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW)
On-treatment, Period 2 Day 27, n=12
|
12.90 Percentage of EDW
Standard Deviation 0.624
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW)
Follow-up, Period 1 Day 13, n=1
|
13.40 Percentage of EDW
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW)
Follow-up, Period 2 Day 21, n=1
|
13.60 Percentage of EDW
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW)
Follow-up, Period 2 Day 27, n=1
|
12.40 Percentage of EDW
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW)
Follow-up, n=15
|
12.90 Percentage of EDW
Standard Deviation 0.535
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)Population: Safety Population.
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).
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
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.
|
|---|---|---|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Protein, Day -1, n=15
|
67.9 Grams per Liter
Standard Deviation 3.98
|
—
|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Protein, On-treatment, Period 1 Day 13, n=14
|
67.3 Grams per Liter
Standard Deviation 3.22
|
—
|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Protein, On-treatment, Period 2 Day 27, n=12
|
65.8 Grams per Liter
Standard Deviation 4.00
|
—
|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Protein, Follow-up, Period 1 Day 13, n=1
|
60.0 Grams per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Protein, Follow-up, Period 2 Day 21, n=1
|
63.0 Grams per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Protein, Follow-up, Period 2 Day 27, n=1
|
70.0 Grams per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Protein, Follow-up, n=15
|
63.7 Grams per Liter
Standard Deviation 2.55
|
—
|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Albumin, Day -1, n=15
|
45.2 Grams per Liter
Standard Deviation 1.90
|
—
|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Albumin, On-treatment, Period 1 Day 13, n=14
|
44.2 Grams per Liter
Standard Deviation 2.58
|
—
|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Albumin, On-treatment, Period 2 Day 21, n=13
|
43.4 Grams per Liter
Standard Deviation 2.06
|
—
|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Albumin, On-treatment, Period 2 Day 27, n=12
|
43.7 Grams per Liter
Standard Deviation 1.87
|
—
|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Albumin, Follow-up, Period 1 Day 13, n=1
|
38.0 Grams per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Albumin, Follow-up, Period 2 Day 21, n=1
|
44.0 Grams per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Albumin, Follow-up, Period 2 Day 27, n=1
|
42.0 Grams per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Albumin, Follow-up, n=15
|
42.7 Grams per Liter
Standard Deviation 1.59
|
—
|
|
Assessment of Clinical Chemistry Parameters: Albumin and Protein
Protein, On-treatment, Period 2 Day 21, n=13
|
65.1 Grams per Liter
Standard Deviation 3.82
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)Population: Safety Population.
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).
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
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.
|
|---|---|---|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALP, Day -1, n=15
|
62.7 International units per Liter
Standard Deviation 14.52
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALP, On-treatment, Period 1 Day 13, n=14
|
60.1 International units per Liter
Standard Deviation 14.34
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALP, On-treatment, Period 2 Day 21, n=13
|
60.7 International units per Liter
Standard Deviation 13.94
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALP, On-treatment, Period 2 Day 27, n=12
|
59.9 International units per Liter
Standard Deviation 17.83
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALP, Follow-up, Period 1 Day 13, n=1
|
51.0 International units per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALP, Follow-up, Period 2 Day 21, n=1
|
61.0 International units per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALP, Follow-up, Period 2 Day 27, n=1
|
56.0 International units per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALP, Follow-up, n=15
|
60.7 International units per Liter
Standard Deviation 13.35
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALT, Day -1, n=15
|
23.5 International units per Liter
Standard Deviation 7.07
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALT, On-treatment, Period 1 Day 13, n=14
|
25.5 International units per Liter
Standard Deviation 8.83
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALT, On-treatment, Period 2 Day 21, n=13
|
30.2 International units per Liter
Standard Deviation 20.12
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALT, On-treatment, Period 2 Day 27, n=12
|
30.8 International units per Liter
Standard Deviation 29.65
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALT, Follow-up, Period 1 Day 13, n=1
|
155.0 International units per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALT, Follow-up, Period 2 Day 21, n=1
|
39.0 International units per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALT, Follow-up, Period 2 Day 27, n=1
|
34.0 International units per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
ALT, Follow-up, n=15
|
37.3 International units per Liter
Standard Deviation 23.40
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
AST, Day -1, n=15
|
18.5 International units per Liter
Standard Deviation 3.62
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
AST, On-treatment, Period 1 Day 13, n=14
|
20.7 International units per Liter
Standard Deviation 6.85
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
AST, On-treatment, Period 2 Day 21, n=13
|
20.9 International units per Liter
Standard Deviation 5.87
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
AST, On-treatment, Period 2 Day 27, n=12
|
23.3 International units per Liter
Standard Deviation 11.48
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
AST, Follow-up, Period 1 Day 13, n=1
|
83.0 International units per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
AST, Follow-up, Period 2 Day 21, n=1
|
26.0 International units per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
AST, Follow-up, Period 2 Day 27, n=1
|
37.0 International units per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
AST, Follow-up, n=15
|
24.9 International units per Liter
Standard Deviation 9.44
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
CK, Day -1, n=15
|
133.6 International units per Liter
Standard Deviation 40.31
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
CK, On-treatment, Period 1 Day 13, n=14
|
227.1 International units per Liter
Standard Deviation 303.97
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
CK, On-treatment, Period 2 Day 21, n=13
|
104.2 International units per Liter
Standard Deviation 43.44
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
CK, On-treatment, Period 2 Day 27, n=12
|
88.7 International units per Liter
Standard Deviation 42.09
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
CK, Follow-up, Period 1 Day 13, n=1
|
1278.0 International units per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
CK, Follow-up, Period 2 Day 21, n=1
|
177.0 International units per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
CK, Follow-up, Period 2 Day 27, n=1
|
164.0 International units per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
CK, Follow-up, n=15
|
144.3 International units per Liter
Standard Deviation 80.81
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
GGT, Day -1, n=15
|
25.5 International units per Liter
Standard Deviation 14.97
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
GGT, On-treatment, Period 1 Day 13, n=14
|
22.6 International units per Liter
Standard Deviation 13.20
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
GGT, On-treatment, Period 2 Day 21, n=13
|
26.8 International units per Liter
Standard Deviation 23.95
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
GGT, On-treatment, Period 2 Day 27, n=12
|
28.1 International units per Liter
Standard Deviation 28.25
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
GGT, Follow-up, Period 1 Day 13, n=1
|
17.0 International units per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
GGT, Follow-up, Period 2 Day 21, n=1
|
36.0 International units per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
GGT, Follow-up, Period 2 Day 27, n=1
|
82.0 International units per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)
GGT, Follow-up, n=15
|
36.1 International units per Liter
Standard Deviation 33.77
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)Population: Safety Population.
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).
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
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.
|
|---|---|---|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
DB, Day -1, n=15
|
3.5 Micromoles per Liter
Standard Deviation 2.00
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
DB, On-treatment, Period 1 Day 13, n=14
|
3.5 Micromoles per Liter
Standard Deviation 1.83
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
DB, On-treatment, Period 2 Day 21, n=13
|
2.4 Micromoles per Liter
Standard Deviation 1.45
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
DB, On-treatment, Period 2 Day 27, n=12
|
2.2 Micromoles per Liter
Standard Deviation 1.19
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
DB, Follow-up, Period 1 Day 13, n=1
|
4.0 Micromoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
DB, Follow-up, Period 2 Day 21, n=1
|
1.0 Micromoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
DB, Follow-up, Period 2 Day 27, n=1
|
2.0 Micromoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
DB, Follow-up, n=15
|
2.9 Micromoles per Liter
Standard Deviation 1.39
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Bilirubin, Day -1, n=15
|
9.8 Micromoles per Liter
Standard Deviation 6.72
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Bilirubin, On-treatment, Period 1 Day 13, n=14
|
10.1 Micromoles per Liter
Standard Deviation 5.83
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Bilirubin, On-treatment, Period 2 Day 21, n=13
|
6.6 Micromoles per Liter
Standard Deviation 4.74
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Bilirubin, On-treatment, Period 2 Day 27, n=12
|
5.3 Micromoles per Liter
Standard Deviation 2.99
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Bilirubin, Follow-up, Period 1 Day 13, n=1
|
10.0 Micromoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Bilirubin, Follow-up, Period 2 Day 21, n=1
|
3.0 Micromoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Bilirubin, Follow-up, Period 2 Day 27, n=1
|
5.0 Micromoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Bilirubin, Follow-up, n=15
|
7.9 Micromoles per Liter
Standard Deviation 3.83
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Creatinine, Day -1, n=15
|
83.1 Micromoles per Liter
Standard Deviation 7.71
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Creatinine, On-treatment, Period 1 Day 13, n=14
|
85.9 Micromoles per Liter
Standard Deviation 11.02
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Creatinine, On-treatment, Period 2 Day 21, n=13
|
88.4 Micromoles per Liter
Standard Deviation 9.43
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Creatinine, On-treatment, Period 2 Day 27, n=12
|
83.8 Micromoles per Liter
Standard Deviation 10.69
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Creatinine, Follow-up, Period 1 Day 13, n=1
|
64.0 Micromoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Creatinine, Follow-up, Period 2 Day 27, n=1
|
91.0 Micromoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Creatinine, Follow-up, n=15
|
80.7 Micromoles per Liter
Standard Deviation 9.65
|
—
|
|
Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine
Creatinine, Follow-up, Period 2 Day 21, n=1
|
71.0 Micromoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)Population: Safety Population.
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).
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
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.
|
|---|---|---|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Calcium, Day -1, n=15
|
2.31 Millimoles per Liter
Standard Deviation 0.0539
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Calcium, On-treatment, Period 1 Day 13, n=14
|
2.34 Millimoles per Liter
Standard Deviation 0.0770
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Calcium, On-treatment, Period 2 Day 21, n=13
|
2.29 Millimoles per Liter
Standard Deviation 0.0720
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Calcium, On-treatment, Period 2 Day 27, n=12
|
2.28 Millimoles per Liter
Standard Deviation 0.0844
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Calcium, Follow-up, Period 1 Day 13, n=1
|
2.27 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Calcium, Follow-up, Period 2 Day 21, n=1
|
2.38 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Calcium, Follow-up, Period 2 Day 27, n=1
|
2.06 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Calcium, Follow-up, n=15
|
2.28 Millimoles per Liter
Standard Deviation 0.0400
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Chloride, Day -1, n=15
|
101.0 Millimoles per Liter
Standard Deviation 1.73
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Chloride, On-treatment, Period 1 Day 13, n=14
|
100.5 Millimoles per Liter
Standard Deviation 1.45
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Chloride, On-treatment, Period 2 Day 21, n=13
|
101.1 Millimoles per Liter
Standard Deviation 2.40
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Chloride, On-treatment, Period 2 Day 27, n=12
|
101.8 Millimoles per Liter
Standard Deviation 2.14
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Chloride, Follow-up, Period 1 Day 13, n=1
|
101.0 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Chloride, Follow-up, Period 2 Day 21, n=1
|
100.0 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Chloride, Follow-up, Period 2 Day 27, n=1
|
99.0 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Chloride, Follow-up, n=15
|
102.5 Millimoles per Liter
Standard Deviation 2.07
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Carbon Dioxide, Day -1, n=15
|
25.6 Millimoles per Liter
Standard Deviation 1.12
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Carbon Dioxide, On-treatment, Period 1 Day13, n=14
|
25.3 Millimoles per Liter
Standard Deviation 1.38
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Carbon Dioxide, On-treatment, Period 2 Day21, n=13
|
27.4 Millimoles per Liter
Standard Deviation 2.10
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Carbon Dioxide, On-treatment, Period 2 Day27, n=12
|
24.7 Millimoles per Liter
Standard Deviation 3.11
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Carbon Dioxide, Follow-up, Period 1 Day 13, n=1
|
25.0 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Carbon Dioxide, Follow-up, Period 2 Day 21, n=1
|
27.0 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Carbon Dioxide, Follow-up, Period 2 Day 27, n=1
|
20.0 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Carbon Dioxide, Follow-up, n=15
|
25.7 Millimoles per Liter
Standard Deviation 1.76
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Glucose, Day -1, n=15
|
5.27 Millimoles per Liter
Standard Deviation 1.077
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Glucose, On-treatment, Period 1 Day 13, n=14
|
5.51 Millimoles per Liter
Standard Deviation 0.487
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Glucose, On-treatment, Period 2 Day 21, n=13
|
5.45 Millimoles per Liter
Standard Deviation 0.399
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Glucose, On-treatment, Period 2 Day 27, n=12
|
5.95 Millimoles per Liter
Standard Deviation 1.103
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Glucose, Follow-up, Period 1 Day 13, n=1
|
5.00 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Glucose, Follow-up, Period 2 Day 21, n=1
|
5.40 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Glucose, Follow-up, Period 2 Day 27, n=1
|
6.00 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Glucose, Follow-up, n=15
|
5.35 Millimoles per Liter
Standard Deviation 0.374
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Potassium, Day -1, n=15
|
4.22 Millimoles per Liter
Standard Deviation 0.166
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Potassium, On-treatment, Period 1 Day 13, n=14
|
4.29 Millimoles per Liter
Standard Deviation 0.250
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Potassium, On-treatment, Period 2 Day 21, n=13
|
4.36 Millimoles per Liter
Standard Deviation 0.386
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Potassium, On-treatment, Period 2 Day 27, n=12
|
4.29 Millimoles per Liter
Standard Deviation 0.247
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Potassium, Follow-up, Period 1 Day 13, n=1
|
3.90 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Potassium, Follow-up, Period 2 Day 21, n=1
|
4.00 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Potassium, Follow-up, Period 2 Day 27, n=1
|
4.10 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Potassium, Follow-up, n=15
|
4.31 Millimoles per Liter
Standard Deviation 0.183
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Sodium, Day -1, n=15
|
141.1 Millimoles per Liter
Standard Deviation 1.28
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Sodium, On-treatment, Period 1 Day 13, n=14
|
139.6 Millimoles per Liter
Standard Deviation 1.82
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Sodium, On-treatment, Period 2 Day 21, n=13
|
140.3 Millimoles per Liter
Standard Deviation 2.36
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Sodium, On-treatment, Period 2 Day 27, n=12
|
139.8 Millimoles per Liter
Standard Deviation 2.09
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Sodium, Follow-up, Period 1 Day 13, n=1
|
139.0 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Sodium, Follow-up, Period 2 Day 21, n=1
|
140.0 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Sodium, Follow-up, Period 2 Day 27, n=1
|
137.0 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Sodium, Follow-up, n=15
|
141.1 Millimoles per Liter
Standard Deviation 2.02
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Urea, Day -1, n=15
|
5.73 Millimoles per Liter
Standard Deviation 1.4048
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Urea, On-treatment, Period 1 Day 13, n=14
|
5.19 Millimoles per Liter
Standard Deviation 1.0830
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Urea, On-treatment, Period 2 Day 21, n=13
|
5.69 Millimoles per Liter
Standard Deviation 1.3678
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Urea, On-treatment, Period 2 Day 27, n=12
|
5.18 Millimoles per Liter
Standard Deviation 1.2104
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Urea, Follow-up, Period 1 Day 13, n=1
|
4.69 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Urea, Follow-up, Period 2 Day 21, n=1
|
2.79 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Urea, Follow-up, Period 2 Day 27, n=1
|
4.09 Millimoles per Liter
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea
Urea, Follow-up, n=15
|
5.34 Millimoles per Liter
Standard Deviation 1.2189
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)Population: Safety Population.
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.
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
n=14 Participants
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.
|
|---|---|---|
|
Number of Participants With Abnormal Urinalysis Result
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1, 14, 21, 28 and follow-up (10 to 14 days after last dose)Population: Safety Population.
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).
Outcome measures
| Measure |
CAB 30 mg
n=14 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
n=12 Participants
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.
|
|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to follow-up (10 to 14 days after last dose)Population: Safety Population.
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).
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
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.
|
|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, On-treatment, Period 1 Day 14, n=14
|
-2.5 Millimeters of Mercury
Standard Deviation 9.17
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, On-treatment, Period 2 Day 21, n=13
|
1.5 Millimeters of Mercury
Standard Deviation 11.90
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, On-treatment, Period 2 Day 28, n=12
|
0.5 Millimeters of Mercury
Standard Deviation 8.74
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Follow-up, Period 2 Day 21, n=1
|
17.0 Millimeters of Mercury
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP, Follow-up, n=15
|
3.7 Millimeters of Mercury
Standard Deviation 12.85
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, On-treatment, Period 1 Day 14, n=14
|
0.8 Millimeters of Mercury
Standard Deviation 7.61
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, On-treatment, Period 2 Day 21, n=13
|
2.0 Millimeters of Mercury
Standard Deviation 9.10
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, On-treatment, Period 2 Day 28, n=12
|
-1.6 Millimeters of Mercury
Standard Deviation 4.21
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Follow-up, Period 2 Day 21, n=1
|
9.5 Millimeters of Mercury
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP, Follow-up, n=15
|
3.3 Millimeters of Mercury
Standard Deviation 9.04
|
—
|
SECONDARY outcome
Timeframe: Baseline to follow-up (10 to 14 days after last dose)Population: Safety Population.
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).
Outcome measures
| Measure |
CAB 30 mg
n=15 Participants
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
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.
|
|---|---|---|
|
Change From Baseline in Pulse Rate
On-treatment, Period 1 Day 14, n=14
|
-4.5 Beats/minute
Standard Deviation 8.31
|
—
|
|
Change From Baseline in Pulse Rate
On-treatment, Period 2 Day 21, n=13
|
-6.2 Beats/minute
Standard Deviation 9.98
|
—
|
|
Change From Baseline in Pulse Rate
On-treatment, Period 2 Day 28, n=12
|
3.4 Beats/minute
Standard Deviation 9.52
|
—
|
|
Change From Baseline in Pulse Rate
Follow-up, Period 2 Day 21, n=1
|
39.0 Beats/minute
Standard Deviation NA
NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived.
|
—
|
|
Change From Baseline in Pulse Rate
Follow-up, n=15
|
-1.3 Beats/minute
Standard Deviation 10.58
|
—
|
Adverse Events
CAB 30 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
RBT 300 mg + CAB 30 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAB 30 mg
n=15 participants at risk
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
n=14 participants at risk
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.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
7.1%
1/14 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
Other adverse events
| Measure |
CAB 30 mg
n=15 participants at risk
Eligible participants received CAB 30 mg oral tablets once daily for 14 days (Day 1 to Day 14) during Period 1.
|
RBT 300 mg + CAB 30 mg
n=14 participants at risk
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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/15 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
7.1%
1/14 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/15 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
7.1%
1/14 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
7.1%
1/14 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
|
Infections and infestations
Viral infection
|
0.00%
0/15 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
7.1%
1/14 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
0.00%
0/14 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/15 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
7.1%
1/14 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.7%
1/15 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
0.00%
0/14 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
|
Investigations
Body temperature increased
|
0.00%
0/15 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
7.1%
1/14 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/15 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
7.1%
1/14 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
7.1%
1/14 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/15 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
7.1%
1/14 • AEs and SAEs were collected from start of the study up to follow-up (up to 10 weeks).
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER