Trial Outcomes & Findings for Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects (NCT NCT04053023)
NCT ID: NCT04053023
Last Updated: 2020-07-24
Results Overview
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Pharmacokinetic (PK) Parameters Population consisted of all participants for whom pharmacokinetic parameters were derivable.
COMPLETED
PHASE1
19 participants
Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dose
2020-07-24
Participant Flow
This was an open-label, drug interaction study to investigate the effect of linerixibat on plasma concentrations of obeticholic acid (OCA) and OCA conjugates in healthy participants. The study was conducted at a single center in the United Kingdom.
A total of 19 participants were enrolled in Part A. Part B was optional and since there was no clinical benefit seen in conducting Part B of this study, no participants were enrolled in Part B. The study was concluded following completion of Part A.
Participant milestones
| Measure |
Part A: OCA 10 mg Followed by OCA 10 mg + Linerixibat 90 mg
In Period 1, participants received OCA 10 milligram (mg), tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19). In Period 2 participants were administered OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (study Day 20 to Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (study Day 20 to the morning of Day 38). There was no washout period between Period 1 and Period 2.
|
Part B: OCA 5mg or 10mg Followed by OCA 10mg+Linerixibat 180mg
In Part B, participants were planned to receive OCA 5 mg or 10 mg, tablets, orally, once daily (evening dose) for 19 days (study Day 1 to Day 19) in Period 1; followed by OCA 10 mg, tablets, orally, once daily (evening dose) for 18 days (study Day 20 to Day 37) along with linerixibat 180 mg, tablets, orally, once daily for 18.5 days (study Day 20 to the morning of Day 38) in Period 2. There was no planned washout period between Period 1 and Period 2.
|
|---|---|---|
|
Part A: Period 1 (Day 1 to Day 19)
STARTED
|
19
|
0
|
|
Part A: Period 1 (Day 1 to Day 19)
COMPLETED
|
19
|
0
|
|
Part A: Period 1 (Day 1 to Day 19)
NOT COMPLETED
|
0
|
0
|
|
Part A: Period 2 (Day 20 to Day 38)
STARTED
|
19
|
0
|
|
Part A: Period 2 (Day 20 to Day 38)
COMPLETED
|
18
|
0
|
|
Part A: Period 2 (Day 20 to Day 38)
NOT COMPLETED
|
1
|
0
|
|
Part B: Period 1 (Day 1 to Day 19)
STARTED
|
0
|
0
|
|
Part B: Period 1 (Day 1 to Day 19)
COMPLETED
|
0
|
0
|
|
Part B: Period 1 (Day 1 to Day 19)
NOT COMPLETED
|
0
|
0
|
|
Part B: Period 2 (Day 20 to Day 38)
STARTED
|
0
|
0
|
|
Part B: Period 2 (Day 20 to Day 38)
COMPLETED
|
0
|
0
|
|
Part B: Period 2 (Day 20 to Day 38)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: OCA 10 mg Followed by OCA 10 mg + Linerixibat 90 mg
In Period 1, participants received OCA 10 milligram (mg), tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19). In Period 2 participants were administered OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (study Day 20 to Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (study Day 20 to the morning of Day 38). There was no washout period between Period 1 and Period 2.
|
Part B: OCA 5mg or 10mg Followed by OCA 10mg+Linerixibat 180mg
In Part B, participants were planned to receive OCA 5 mg or 10 mg, tablets, orally, once daily (evening dose) for 19 days (study Day 1 to Day 19) in Period 1; followed by OCA 10 mg, tablets, orally, once daily (evening dose) for 18 days (study Day 20 to Day 37) along with linerixibat 180 mg, tablets, orally, once daily for 18.5 days (study Day 20 to the morning of Day 38) in Period 2. There was no planned washout period between Period 1 and Period 2.
|
|---|---|---|
|
Part A: Period 2 (Day 20 to Day 38)
Adverse Event
|
1
|
0
|
Baseline Characteristics
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Part A: OCA 10 mg Followed by OCA 10 mg + Linerixibat 90 mg
n=19 Participants
In Period 1, participants received OCA 10 milligram (mg), tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19). In Period 2 participants were administered OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (study Day 20 to Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (study Day 20 to the morning of Day 38). There was no washout period between Period 1 and Period 2.
|
Part B: OCA 5mg or 10mg Followed by OCA 10mg+Linerixibat 180mg
In Part B, participants were planned to receive OCA 5 mg or 10 mg, tablets, orally, once daily (evening dose) for 19 days (study Day 1 to Day 19) in Period 1; followed by OCA 10 mg, tablets, orally, once daily (evening dose) for 18 days (study Day 20 to Day 37) along with linerixibat 180 mg, tablets, orally, once daily for 18.5 days (study Day 20 to the morning of Day 38) in Period 2. There was no planned washout period between Period 1 and Period 2.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.9 Years
STANDARD_DEVIATION 10.28 • n=5 Participants
|
—
|
44.9 Years
STANDARD_DEVIATION 10.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
—
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
18 Participants
n=5 Participants
|
—
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Pharmacokinetic (PK) Parameters Population consisted of all participants for whom pharmacokinetic parameters were derivable.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-t]) for Total-OCA at Steady State: OCA Arm
|
2329.804 Hours*nanogram per milliliter
Geometric Coefficient of Variation 43.54
|
—
|
PRIMARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- AUC(0-t) for Total-OCA at Steady State: OCA + Linerixibat Arm
|
782.528 Hours*nanogram per milliliter
Geometric Coefficient of Variation 55.81
|
—
|
PRIMARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Area Under the Concentration-time Curve From Time 0 to 24 Hour (AUC[0-24]) for Total-OCA at Steady State: OCA Arm
|
2349.552 Hours*nanogram per milliliter
Geometric Coefficient of Variation 43.55
|
—
|
PRIMARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- AUC(0-24) for Total-OCA at Steady State: OCA + Linerixibat Arm
|
787.007 Hours*nanogram per milliliter
Geometric Coefficient of Variation 55.17
|
—
|
PRIMARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Maximum Observed Concentration (Cmax) for Total-OCA at Steady State: OCA Arm
|
206.409 Nanogram per milliliter
Geometric Coefficient of Variation 41.18
|
—
|
PRIMARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Cmax for Total-OCA at Steady State: OCA + Linerixibat Arm
|
83.403 Nanogram per milliliter
Geometric Coefficient of Variation 45.55
|
—
|
PRIMARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Average of Ctrough measurement from study Days 17, 18 and 19 has been presented.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Average Trough Concentration (Ctrough) for Total-OCA at Steady State: OCA Arm
|
85.312 Nanogram per milliliter
Geometric Coefficient of Variation 53.13
|
—
|
PRIMARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Average of Ctrough measurement from study Days 35, 36, 37 and 38 has been presented.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Average Ctrough for Total-OCA at Steady State: OCA + Linerixibat Arm
|
21.680 Nanogram per milliliter
Geometric Coefficient of Variation 85.11
|
—
|
PRIMARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of total-OCA.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of total-OCA.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of total-OCA.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of total-OCA.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of total-OCA.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of total-OCA.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of total-OCA.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of total-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Time to Reach Maximum Observed Plasma Concentration (Tmax) for Total-OCA: OCA Arm
|
1.00 Hours
Interval 0.3 to 5.0
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Tmax for Total-OCA: OCA + Linerixibat Arm
|
3.00 Hours
Interval 0.5 to 6.0
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 hours and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Assessment of Steady State Using Ctrough of Total-OCA: OCA Arm
Day 17
|
92.1116 Nanogram per milliliter
Standard Deviation 57.86113
|
—
|
|
Part A- Assessment of Steady State Using Ctrough of Total-OCA: OCA Arm
Day 18
|
95.1600 Nanogram per milliliter
Standard Deviation 57.50955
|
—
|
|
Part A- Assessment of Steady State Using Ctrough of Total-OCA: OCA Arm
Day 19
|
102.5168 Nanogram per milliliter
Standard Deviation 66.65649
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 hours and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of total-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Assessment of Steady State Using Ctrough of Total-OCA: OCA + Linerixibat Arm
Day 35
|
30.8972 Nanogram per milliliter
Standard Deviation 25.55139
|
—
|
|
Part A- Assessment of Steady State Using Ctrough of Total-OCA: OCA + Linerixibat Arm
Day 36
|
28.8489 Nanogram per milliliter
Standard Deviation 27.08479
|
—
|
|
Part A- Assessment of Steady State Using Ctrough of Total-OCA: OCA + Linerixibat Arm
Day 37
|
26.4411 Nanogram per milliliter
Standard Deviation 21.63264
|
—
|
|
Part A- Assessment of Steady State Using Ctrough of Total-OCA: OCA + Linerixibat Arm
Day 38
|
27.8644 Nanogram per milliliter
Standard Deviation 21.08848
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- AUC(0-t) for OCA: OCA Arm
|
158.337 Hours*nanogram per milliliter
Geometric Coefficient of Variation 59.45
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- AUC(0-t) for OCA: OCA + Linerixibat Arm
|
127.171 Hours*nanogram per milliliter
Geometric Coefficient of Variation 53.12
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- AUC(0-24) for OCA: OCA Arm
|
163.701 Hours*nanogram per milliliter
Geometric Coefficient of Variation 59.51
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=17 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- AUC(0-24) for OCA: OCA + Linerixibat Arm
|
130.092 Hours * nanogram per milliliter
Geometric Coefficient of Variation 53.80
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Cmax for OCA: OCA Arm
|
50.820 Nanogram per milliliter
Geometric Coefficient of Variation 71.94
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Cmax for OCA: OCA + Linerixibat Arm
|
35.495 Nanogram per milliliter
Geometric Coefficient of Variation 61.88
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Average of Ctrough measurement from study Days 17, 18 and 19 has been presented.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Average Ctrough for OCA: OCA Arm
|
2.609 Nanogram per milliliter
Geometric Coefficient of Variation 69.77
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Average of Ctrough measurement from study Days 35, 36, 37 and 38 has been presented.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Average Ctrough for OCA: OCA + Linerixibat Arm
|
2.060 Nanogram per milliliter
Geometric Coefficient of Variation 83.57
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Tmax for OCA: OCA Arm
|
0.75 Hours
Interval 0.3 to 11.0
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Tmax for OCA: OCA + Linerixibat Arm
|
0.88 Hours
Interval 0.5 to 12.0
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- AUC(0-t) for Tauro-OCA: OCA Arm
|
712.567 Hours*nanogram per milliliter
Geometric Coefficient of Variation 61.28
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- AUC(0-t) for Tauro-OCA: OCA + Linerixibat Arm
|
89.486 Hours*nanogram per milliliter
Geometric Coefficient of Variation 64.85
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=15 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- AUC(0-24) for Tauro-OCA: OCA Arm
|
744.365 Hours*nanogram per milliliter
Geometric Coefficient of Variation 68.92
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- AUC(0-24) for Tauro-OCA: OCA + Linerixibat Arm
|
89.946 Hours*nanogram per milliliter
Geometric Coefficient of Variation 64.50
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Cmax for Tauro-OCA: OCA Arm
|
62.347 Nanogram per milliliter
Geometric Coefficient of Variation 60.84
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Cmax for Tauro-OCA: OCA + Linerixibat Arm
|
10.224 Nanogram per milliliter
Geometric Coefficient of Variation 61.53
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Average of Ctrough measurement from study Days 17, 18 and 19 has been presented.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Average Ctrough for Tauro-OCA: OCA Arm
|
28.014 Nanogram per milliliter
Geometric Coefficient of Variation 76.45
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Average of Ctrough measurement from study Days 35, 36, 37 and 38 has been presented.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Average Ctrough for Tauro-OCA: OCA + Linerixibat Arm
|
2.600 Nanogram per milliliter
Geometric Coefficient of Variation 124.06
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Tmax for Tauro-OCA: OCA Arm
|
2.00 Hours
Interval 0.3 to 11.0
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of tauro-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Tmax for Tauro-OCA: OCA + Linerixibat Arm
|
5.00 Hours
Interval 2.0 to 9.0
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- AUC(0-t) for Glyco-OCA: OCA Arm
|
1741.969 Hours*nanogram per milliliter
Geometric Coefficient of Variation 44.11
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- AUC(0-t) for Glyco-OCA: OCA + Linerixibat Arm
|
650.683 Hours*nanogram per milliliter
Geometric Coefficient of Variation 58.17
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- AUC(0-24) for Glyco-OCA: OCA Arm
|
1757.140 Hours*nanogram per milliliter
Geometric Coefficient of Variation 44.10
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- AUC(0-24) for Glyco-OCA: OCA + Linerixibat Arm
|
654.629 Hours*nanogram per milliliter
Geometric Coefficient of Variation 57.45
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Cmax for Glyco-OCA: OCA Arm
|
141.770 Nanogram per milliliter
Geometric Coefficient of Variation 39.46
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Cmax for Glyco-OCA: OCA + Linerixibat Arm
|
65.633 Nanogram per milliliter
Geometric Coefficient of Variation 50.27
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Average of Ctrough measurement from study Days 17, 18 and 19 has been presented.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Average Ctrough for Glyco-OCA: OCA Arm
|
66.043 Nanogram per milliliter
Geometric Coefficient of Variation 50.72
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis. Average of Ctrough measurement from study Days 35, 36, 37 and 38 has been presented.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Average Ctrough for Glyco-OCA: OCA + Linerixibat Arm
|
19.498 Nanogram per milliliter
Geometric Coefficient of Variation 85.88
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population.
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Tmax for Glyco-OCA: OCA Arm
|
2.00 Hours
Interval 0.3 to 5.0
|
—
|
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for pharmacokinetic analysis of glyco-OCA. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Tmax for Glyco-OCA: OCA + Linerixibat Arm
|
5.00 Hours
Interval 1.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of total-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of total-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of tauro-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 17: Pre-dose; Day 18: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 19) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 35 and 36: Pre-dose; Day 37: Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14 and 24 hours (Day 38) post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of glyco-OCA.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Day 52Population: All Participants Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. All Participants Population consisted of all participants who took at least 1 dose of study intervention.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any AEs
|
10 Participants
|
14 Participants
|
|
Part A- Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAEs
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 52Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1), and at Day 17Population: All Participants Population.
Twelve lead electrocardiograms (ECGs) were obtained to measure PR interval, QRS duration, QT interval, QTcB and QTcF. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 5 minutes. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected Using Bazzet's Formula (QTcB), Corrected QT Interval Using Fredericia's Formula (QTcF): OCA Arm
PR Interval
|
-3.7 Millisecond
Standard Deviation 8.27
|
—
|
|
Part A- Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected Using Bazzet's Formula (QTcB), Corrected QT Interval Using Fredericia's Formula (QTcF): OCA Arm
QRS Duration
|
-1.2 Millisecond
Standard Deviation 4.66
|
—
|
|
Part A- Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected Using Bazzet's Formula (QTcB), Corrected QT Interval Using Fredericia's Formula (QTcF): OCA Arm
QT Interval
|
-3.4 Millisecond
Standard Deviation 14.56
|
—
|
|
Part A- Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected Using Bazzet's Formula (QTcB), Corrected QT Interval Using Fredericia's Formula (QTcF): OCA Arm
QTcB Interval
|
4.2 Millisecond
Standard Deviation 13.31
|
—
|
|
Part A- Change From Baseline in PR Interval, QRS Duration, QT Interval, QT Interval Corrected Using Bazzet's Formula (QTcB), Corrected QT Interval Using Fredericia's Formula (QTcF): OCA Arm
QTcF Interval
|
1.6 Millisecond
Standard Deviation 10.43
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), and at Day 38Population: All Participants Population. Only those participants with data available at the specified time points were analyzed.
Twelve lead ECGs were obtained to measure PR interval, QRS duration, QT interval, QTcB and QTcF. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 5 minutes. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcB, QTcF: OCA + Linerixibat Arm
QT Interval
|
-2.7 Millisecond
Standard Deviation 13.05
|
—
|
|
Part A- Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcB, QTcF: OCA + Linerixibat Arm
PR Interval
|
2.5 Millisecond
Standard Deviation 12.96
|
—
|
|
Part A- Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcB, QTcF: OCA + Linerixibat Arm
QRS Duration
|
-2.3 Millisecond
Standard Deviation 2.97
|
—
|
|
Part A- Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcB, QTcF: OCA + Linerixibat Arm
QTcB Interval
|
-2.9 Millisecond
Standard Deviation 13.18
|
—
|
|
Part A- Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcB, QTcF: OCA + Linerixibat Arm
QTcF Interval
|
-2.9 Millisecond
Standard Deviation 9.58
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
Twelve lead ECGs were planned to be measured PR interval, QRS duration, QT interval, QTcB and QTcF. Twelve-lead ECGs were planned to be performed with the participant in a supine position after a rest of at least 5 minutes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1), Days 1 and 17Population: All Participants Population.
SBP and DBP were measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): OCA Arm
SBP: Day 1
|
-0.9 Millimeters of mercury
Standard Deviation 6.83
|
—
|
|
Part A- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): OCA Arm
SBP: Day 17
|
0.5 Millimeters of mercury
Standard Deviation 5.94
|
—
|
|
Part A- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): OCA Arm
DBP: Day 1
|
-4.5 Millimeters of mercury
Standard Deviation 4.17
|
—
|
|
Part A- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): OCA Arm
DBP: Day 17
|
0.1 Millimeters of mercury
Standard Deviation 3.96
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 38Population: All Participants Population. Only those participants with data available at the specified time points were analyzed.
SBP and DBP were measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in SBP and DBP: OCA + Linerixibat Arm
SBP
|
-0.7 Millimeters of mercury
Standard Deviation 8.48
|
—
|
|
Part A- Change From Baseline in SBP and DBP: OCA + Linerixibat Arm
DBP
|
0.8 Millimeters of mercury
Standard Deviation 2.98
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Days 1 and 17Population: All Participants Population.
Pulse rate was measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Pulse Rate: OCA Arm
Day 1
|
7.2 Beats per minute
Standard Deviation 6.54
|
—
|
|
Part A- Change From Baseline in Pulse Rate: OCA Arm
Day 17
|
1.8 Beats per minute
Standard Deviation 7.45
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 38Population: All Participants Population. Only those participants with data available at the specified time points were analyzed.
Pulse rate was measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Pulse Rate: OCA + Linerixibat Arm
|
-0.3 Beats per minute
Standard Deviation 8.96
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Days 1 and 17Population: All Participants Population.
Respiratory rate was measured in supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Respiratory Rate: OCA Arm
Day 1
|
0.2 Breaths per minute
Standard Deviation 1.95
|
—
|
|
Part A- Change From Baseline in Respiratory Rate: OCA Arm
Day 17
|
0.4 Breaths per minute
Standard Deviation 1.77
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 38Population: All Participants Population. Only those participants with data available at the specified time points were analyzed.
Respiratory rate was measured in supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Respiratory Rate: OCA + Linerixibat Arm
|
0.4 Breaths per minute
Standard Deviation 2.09
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Days 1 and 17Population: All Participants Population.
Body temperature was measured in supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Body Temperature: OCA Arm
Day 1
|
0.15 Degrees Celsius
Standard Deviation 0.356
|
—
|
|
Part A- Change From Baseline in Body Temperature: OCA Arm
Day 17
|
0.05 Degrees Celsius
Standard Deviation 0.336
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 38Population: All Participants Population. Only those participants with data available at the specified time points were analyzed.
Body temperature was measured in supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Body Temperature: OCA + Linerixibat Arm
|
0.09 Degrees Celsius
Standard Deviation 0.327
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
SBP and DBP were planned to be measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
Pulse rate was planned to be measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
Respiratory rate was planned to be measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
Body temperature was planned to be measured in a supine position after 5 minutes of rest for the participants in a quiet setting without distractions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 17Population: All Participants Population.
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count and leukocytes. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA Arm
Basophils
|
-0.002 10^9 cells per liter
Standard Deviation 0.0144
|
—
|
|
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA Arm
Eosinophils
|
-0.013 10^9 cells per liter
Standard Deviation 0.0549
|
—
|
|
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA Arm
Lymphocytes
|
-0.091 10^9 cells per liter
Standard Deviation 0.4444
|
—
|
|
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA Arm
Monocytes
|
0.033 10^9 cells per liter
Standard Deviation 0.1125
|
—
|
|
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA Arm
Neutrophils
|
0.064 10^9 cells per liter
Standard Deviation 0.8205
|
—
|
|
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA Arm
Platelet count
|
4.3 10^9 cells per liter
Standard Deviation 22.85
|
—
|
|
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA Arm
Leukocytes
|
-0.011 10^9 cells per liter
Standard Deviation 0.7760
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 38Population: All Participants Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count and leukocytes. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA + Linerixibat Arm
Basophils
|
0.000 10^9 cells per liter
Standard Deviation 0.0091
|
—
|
|
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA + Linerixibat Arm
Eosinophils
|
0.029 10^9 cells per liter
Standard Deviation 0.0801
|
—
|
|
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA + Linerixibat Arm
Lymphocytes
|
0.169 10^9 cells per liter
Standard Deviation 0.3534
|
—
|
|
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA + Linerixibat Arm
Monocytes
|
0.047 10^9 cells per liter
Standard Deviation 0.0932
|
—
|
|
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA + Linerixibat Arm
Platelet count
|
-4.1 10^9 cells per liter
Standard Deviation 20.77
|
—
|
|
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA + Linerixibat Arm
Leukocytes
|
0.524 10^9 cells per liter
Standard Deviation 1.1981
|
—
|
|
Part A- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, Leukocytes: OCA + Linerixibat Arm
Neutrophils
|
0.278 10^9 cells per liter
Standard Deviation 1.2073
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 17Population: All Participants Population.
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Hematology Parameter: Hemoglobin: OCA Arm
|
0.4 Grams per liter
Standard Deviation 6.33
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 38Population: All Participants Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Hematology Parameter: Hemoglobin: OCA + Linerixibat Arm
|
-0.8 Grams per liter
Standard Deviation 5.09
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 17Population: All Participants Population.
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Hematology Parameter: Hematocrit: OCA Arm
|
-0.0003 Proportion of red blood cells in blood
Standard Deviation 0.01614
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 38Population: All Participants Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Hematology Parameter: Hematocrit: OCA + Linerixibat Arm
|
-0.0054 Proportion of red blood cells in blood
Standard Deviation 0.01857
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 17Population: All Participants Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin: OCA Arm
|
-0.01 Picograms
Standard Deviation 0.624
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 38Population: All Participants Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin: OCA + Linerixibat Arm
|
-0.13 Picograms
Standard Deviation 0.552
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 17Population: All Participants Population.
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume: OCA Arm
|
-0.37 Femtoliter
Standard Deviation 1.797
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 38Population: All Participants Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume: OCA + Linerixibat Arm
|
-1.03 Femtoliter
Standard Deviation 1.972
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 17Population: All Participants Population.
Blood samples were collected to analyze the hematology parameters: erythrocytes and reticulocytes. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes: OCA Arm
Erythrocytes
|
0.021 10^12 cells per liter
Standard Deviation 0.1919
|
—
|
|
Part A- Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes: OCA Arm
Reticulocytes
|
-0.0004 10^12 cells per liter
Standard Deviation 0.01165
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 38Population: All Participants Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to analyze the hematology parameters: erythrocytes and reticulocytes. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes: OCA + Linerixibat Arm
Erythrocytes
|
0.002 10^12 cells per liter
Standard Deviation 0.2340
|
—
|
|
Part A- Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes: OCA + Linerixibat Arm
Reticulocytes
|
0.0074 10^12 cells per liter
Standard Deviation 0.01650
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count and leukocytes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze the hematology parameter: hemoglobin.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze the hematology parameter: hematocrit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze the hematology parameters: erythrocytes and reticulocytes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 17Population: All Participants Population.
Blood samples were collected to analyze the chemistry parameters: glucose, calcium, potassium, sodium and urea. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea: OCA Arm
Glucose
|
-0.09 Millimoles per liter
Standard Deviation 0.537
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea: OCA Arm
Calcium
|
0.041 Millimoles per liter
Standard Deviation 0.0891
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea: OCA Arm
Potassium
|
-0.02 Millimoles per liter
Standard Deviation 0.429
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea: OCA Arm
Sodium
|
-0.2 Millimoles per liter
Standard Deviation 2.10
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea: OCA Arm
Urea
|
-0.0395 Millimoles per liter
Standard Deviation 0.32717
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 38Population: All Participants Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters: glucose, calcium, potassium, sodium and urea. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea: OCA + Linerixibat Arm
Glucose, n=18
|
-0.44 Millimoles per liter
Standard Deviation 0.343
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea: OCA + Linerixibat Arm
Calcium, n=18
|
-0.001 Millimoles per liter
Standard Deviation 0.0506
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea: OCA + Linerixibat Arm
Potassium, n=16
|
0.10 Millimoles per liter
Standard Deviation 0.493
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea: OCA + Linerixibat Arm
Sodium, n=18
|
-0.9 Millimoles per liter
Standard Deviation 1.89
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea: OCA + Linerixibat Arm
Urea, n=18
|
-0.1507 Millimoles per liter
Standard Deviation 0.24902
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 17Population: All Participants Population.
Blood samples were collected to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin: OCA Arm
Bilirubin
|
0.1 Micromoles per liter
Standard Deviation 2.42
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin: OCA Arm
Creatinine
|
-2.2 Micromoles per liter
Standard Deviation 7.71
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin: OCA Arm
Direct Bilirubin
|
0.0001 Micromoles per liter
Standard Deviation 0.88192
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 38Population: All Participants Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin: OCA + Linerixibat Arm
Bilirubin, n=18
|
1.1 Micromoles per liter
Standard Deviation 2.72
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin: OCA + Linerixibat Arm
Creatinine, n=18
|
5.4 Micromoles per liter
Standard Deviation 6.83
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin: OCA + Linerixibat Arm
Direct Bilirubin, n=16
|
0.3126 Micromoles per liter
Standard Deviation 0.79317
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 17Population: All Participants Population.
Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST): OCA Arm
AST
|
-2.2 International units per liter
Standard Deviation 3.03
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST): OCA Arm
ALT
|
-2.7 International units per liter
Standard Deviation 4.75
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST): OCA Arm
ALP
|
0.6 International units per liter
Standard Deviation 5.50
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 38Population: All Participants Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Chemistry Parameters: ALT, ALP, AST: OCA + Linerixibat Arm
ALT, n=17
|
9.4 International units per liter
Standard Deviation 38.04
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: ALT, ALP, AST: OCA + Linerixibat Arm
ALP, n=18
|
0.0 International units per liter
Standard Deviation 9.49
|
—
|
|
Part A- Change From Baseline in Chemistry Parameters: ALT, ALP, AST: OCA + Linerixibat Arm
AST, n=16
|
-0.9 International units per liter
Standard Deviation 8.50
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 17Population: All Participants Population.
Blood samples were collected to analyze the chemistry parameter: protein. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Chemistry Parameter: Protein: OCA Arm
|
1.5 Grams per liter
Standard Deviation 3.13
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 38Population: All Participants Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected to analyze the chemistry parameter: protein. Baseline was considered as Day -1. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=18 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Change From Baseline in Chemistry Parameter: Protein: OCA + Linerixibat Arm
|
0.7 Grams per liter
Standard Deviation 2.66
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze the chemistry parameters: glucose, calcium, potassium, sodium and urea.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze the chemistry parameters: ALT, ALP and AST.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected to analyze the chemistry parameter: protein.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 17Population: All Participants Population. Only those participants with data available at the indicated time points were analyzed.
Urine samples were collected from participants for urinalysis for measuring potential of hydrogen (pH) and glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocytes levels by dipstick. Abnormal urinalysis was sent for microscopic examination for cellular casts, erythrocytes, granular casts, hyaline casts, and leukocytes and were counted as cells per high-power field (cells/HPF). Baseline was considered as Day -1. Number of participants with worst case urinalysis result by microscopic examination have been presented.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=5 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA Arm
Cellular casts: Increase to 1-9/HPF
|
0 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA Arm
Cellular casts: No change
|
5 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA Arm
Erythrocytes: No change
|
4 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA Arm
Erythrocytes: Increase to 1-9/HPF
|
1 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA Arm
Granular casts: No change
|
5 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA Arm
Granular casts: Increase to 1-9/HPF
|
0 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA Arm
Hyaline casts: No change
|
5 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA Arm
Hyaline casts: Increase to 1-9/HPF
|
0 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA Arm
Leukocytes: No change
|
4 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA Arm
Leukocytes: Increase to 1-9/HPF
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and at Day 38Population: All Participants Population. Only those participants with data available at the indicated time points were analyzed.
Urine samples were collected from participants for urinalysis for measuring pH and glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocytes levels by dipstick. Abnormal urinalysis was sent for microscopic examination for cellular casts, erythrocytes, granular casts, hyaline casts, and leukocytes and were counted as cells/HPF. Baseline was considered as Day -1. Number of participants with worst case urinalysis result by microscopic examination have been presented.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=1 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA + Linerixibat Arm
Cellular casts: No change
|
1 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA + Linerixibat Arm
Cellular casts: Increase to 1-9/HPF
|
0 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA + Linerixibat Arm
Erythrocytes: No change
|
0 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA + Linerixibat Arm
Erythrocytes: Increase to 1-9/HPF
|
1 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA + Linerixibat Arm
Granular casts: No change
|
1 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA + Linerixibat Arm
Granular casts: Increase to 1-9/HPF
|
0 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA + Linerixibat Arm
Hyaline casts: No change
|
1 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA + Linerixibat Arm
Hyaline casts: Increase to 1-9/HPF
|
0 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA + Linerixibat Arm
Leukocytes: No change
|
1 Participants
|
—
|
|
Part A- Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline: OCA + Linerixibat Arm
Leukocytes: Increase to 1-9/HPF
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day -1), and up to Day 38Population: All Participants Population. Data was not collected as no participants were enrolled in Part B.
Urine samples were planned to be collected from participants for urinalysis for measuring pH and glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocytes levels by dipstick. Abnormal urinalysis was planned to be sent for microscopic examination for cellular casts, erythrocytes, granular casts, hyaline casts, and leukocytes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 20 and 33: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Blood samples were collected at indicated time points for pharmacokinetic analysis of linerixibat. Pharmacokinetic parameters were analyzed using standard non-compartmental methods.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- AUC(0-t) for Linerixibat: OCA + Linerixibat Arm
Day 20, n=16
|
230.609 Hours*picogram per milliliter
Geometric Coefficient of Variation 153.14
|
—
|
|
Part A- AUC(0-t) for Linerixibat: OCA + Linerixibat Arm
Day 33, n=19
|
903.881 Hours*picogram per milliliter
Geometric Coefficient of Variation 142.27
|
—
|
SECONDARY outcome
Timeframe: Days 20 and 33: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Blood samples were collected at indicated time points for pharmacokinetic analysis of linerixibat. Pharmacokinetic parameters were analyzed using standard non-compartmental methods.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=17 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) for Linerixibat: OCA + Linerixibat Arm
Day 33, n=17
|
1071.982 Hours*picogram per milliliter
Geometric Coefficient of Variation 144.57
|
—
|
|
Part A- Area Under the Concentration-time Curve From Time Zero to 12 Hours (AUC[0-12]) for Linerixibat: OCA + Linerixibat Arm
Day 20, n=13
|
322.580 Hours*picogram per milliliter
Geometric Coefficient of Variation 121.05
|
—
|
SECONDARY outcome
Timeframe: Days 20 and 33: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Blood samples were collected at indicated time points for pharmacokinetic analysis of linerixibat. Pharmacokinetic parameters were analyzed using standard non-compartmental methods.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Cmax for Linerixibat: OCA + Linerixibat Arm
Day 20, n=17
|
56.927 Picogram per milliliter
Geometric Coefficient of Variation 173.55
|
—
|
|
Part A- Cmax for Linerixibat: OCA + Linerixibat Arm
Day 33, n=19
|
163.624 Picogram per milliliter
Geometric Coefficient of Variation 123.48
|
—
|
SECONDARY outcome
Timeframe: Days 20 and 33: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dosePopulation: PK Parameters Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Blood samples were collected at indicated time points for pharmacokinetic analysis of linerixibat. Pharmacokinetic parameters were analyzed using standard non-compartmental methods.
Outcome measures
| Measure |
Part A: OCA 10 mg
n=19 Participants
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Part A- Tmax for Linerixibat: OCA + Linerixibat Arm
Day 20, n=17
|
3.92 Hours
Interval 0.3 to 8.0
|
—
|
|
Part A- Tmax for Linerixibat: OCA + Linerixibat Arm
Day 33, n=19
|
5.00 Hours
Interval 0.5 to 9.0
|
—
|
SECONDARY outcome
Timeframe: Days 20 and 33: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of linerixibat.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 20 and 33: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of linerixibat.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 20 and 33: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of linerixibat.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 20 and 33: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dosePopulation: PK Parameters Population. Data was not collected as no participants were enrolled in Part B.
Blood samples were planned to be collected at indicated time points for pharmacokinetic analysis of linerixibat.
Outcome measures
Outcome data not reported
Adverse Events
Part A: OCA 10 mg
Part A: OCA 10 mg + Linerixibat 90 mg
Serious adverse events
| Measure |
Part A: OCA 10 mg
n=19 participants at risk
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
n=19 participants at risk
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
Other adverse events
| Measure |
Part A: OCA 10 mg
n=19 participants at risk
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 19 days (study Day 1 to Day 19) in Period 1.
|
Part A: OCA 10 mg + Linerixibat 90 mg
n=19 participants at risk
In Part A, participants received OCA 10 mg, tablets, orally, once daily (afternoon dose) for 18 days (from study Day 20 to the Day 37) along with linerixibat 90 mg, tablets, orally, twice daily for 18.5 days (from study Day 20 to the morning of Day 38) in Period 2.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
26.3%
5/19 • Number of events 5 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
21.1%
4/19 • Number of events 4 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
1/19 • Number of events 2 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Gastrointestinal disorders
Faeces soft
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Gastrointestinal disorders
Flatulence
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Nervous system disorders
Headache
|
21.1%
4/19 • Number of events 4 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Nervous system disorders
Paraesthesia
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
10.5%
2/19 • Number of events 2 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
10.5%
2/19 • Number of events 2 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Infections and infestations
Nasopharyngitis
|
15.8%
3/19 • Number of events 3 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
General disorders
Catheter site pain
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
General disorders
Swelling
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Investigations
Transaminases increased
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
10.5%
2/19 • Number of events 2 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
10.5%
2/19 • Number of events 2 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Vascular disorders
Hot flush
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • Number of events 2 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Psychiatric disorders
Libido increased
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
1/19 • Number of events 1 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
0.00%
0/19 • AEs and SAEs were collected up to Day 52 in Part A
All Participants Population consisted of all participants who took at least 1 dose of study intervention. Data is presented for Part A only as data was not collected for Part B since there was no clinical benefit seen in conducting Part B of this study. The study was concluded following completion of Part A.
|
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