Trial Outcomes & Findings for An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) (NCT NCT04950764)
NCT ID: NCT04950764
Last Updated: 2026-05-04
Results Overview
TEAEs severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants were counted at the highest AE grade experienced. The percentage of participants with any severity grade and severity grade of 3 or 4 were reported. Percentages were rounded off.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Part A: Up to Week 5; Part B: Up to Week 8
Results posted on
2026-05-04
Participant Flow
Participants were enrolled at study sites in the United States, South Korea, Spain, and the United Kingdom.
37 participants were screened.
Participant milestones
| Measure |
Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg)
Participants with primary biliary cholangitis (PBC) and a Child-Pugh (CP) classification of CP-A (score 5 to 6) without portal hypertension (PHT), received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Part A: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Part A: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Part A: Cohort 4 - CP-C (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A
STARTED
|
6
|
6
|
6
|
6
|
0
|
0
|
0
|
0
|
|
Part A
COMPLETED
|
6
|
6
|
6
|
6
|
0
|
0
|
0
|
0
|
|
Part A
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
0
|
5
|
1
|
5
|
1
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
0
|
5
|
1
|
5
|
1
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
Baseline characteristics by cohort
| Measure |
Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) without PHT, received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Part A: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Part A: Cohort 3 - CP-B (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Part A: Cohort 4 - CP-C (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
4 Participants
n=1 Participants
|
19 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
2 Participants
n=1 Participants
|
5 Participants
n=9 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 4.4 • n=54 Participants
|
61 years
STANDARD_DEVIATION 8.0 • n=60 Participants
|
57 years
STANDARD_DEVIATION 13.6 • n=114 Participants
|
61 years
STANDARD_DEVIATION 7.2 • n=1 Participants
|
59 years
STANDARD_DEVIATION 8.6 • n=9 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
6 Participants
n=114 Participants
|
5 Participants
n=1 Participants
|
22 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
2 Participants
n=1 Participants
|
6 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
5 Participants
n=114 Participants
|
4 Participants
n=1 Participants
|
18 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
7 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
5 Participants
n=114 Participants
|
6 Participants
n=1 Participants
|
17 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
South Korea
|
4 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
5 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
5 Participants
n=1 Participants
|
17 Participants
n=9 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=9 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: The PK Analysis Set included all study participants who underwent PK sampling and for whom the PK profile could be adequately characterized based on available and analyzed samples.
Cmax is defined as the maximum observed plasma concentration of the study drug.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Pharmacokinetic (PK) Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Cmax of Seladelpar
|
182.0 nanograms per milliliter (ng/mL)
Standard Deviation 60.68
|
367.7 nanograms per milliliter (ng/mL)
Standard Deviation 238.28
|
359.2 nanograms per milliliter (ng/mL)
Standard Deviation 158.61
|
388.5 nanograms per milliliter (ng/mL)
Standard Deviation 153.45
|
—
|
—
|
—
|
—
|
|
Part A: Pharmacokinetic (PK) Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Cmax of M1
|
20.08 nanograms per milliliter (ng/mL)
Standard Deviation 9.012
|
33.17 nanograms per milliliter (ng/mL)
Standard Deviation 9.913
|
47.27 nanograms per milliliter (ng/mL)
Standard Deviation 22.439
|
40.07 nanograms per milliliter (ng/mL)
Standard Deviation 12.974
|
—
|
—
|
—
|
—
|
|
Part A: Pharmacokinetic (PK) Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Cmax of M2
|
225.3 nanograms per milliliter (ng/mL)
Standard Deviation 117.66
|
257.7 nanograms per milliliter (ng/mL)
Standard Deviation 30.58
|
291.7 nanograms per milliliter (ng/mL)
Standard Deviation 92.68
|
217.7 nanograms per milliliter (ng/mL)
Standard Deviation 36.58
|
—
|
—
|
—
|
—
|
|
Part A: Pharmacokinetic (PK) Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Cmax of M3
|
42.55 nanograms per milliliter (ng/mL)
Standard Deviation 20.510
|
28.78 nanograms per milliliter (ng/mL)
Standard Deviation 6.739
|
34.50 nanograms per milliliter (ng/mL)
Standard Deviation 10.994
|
23.88 nanograms per milliliter (ng/mL)
Standard Deviation 9.182
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: Participants in the PK Analysis Set were analyzed.
Tmax is defined as the time to reach the maximum observed plasma concentration of the study drug.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Tmax of M2
|
5.500 hours (h)
Interval 2.5 to 8.117
|
4.000 hours (h)
Interval 2.017 to 8.0
|
4.000 hours (h)
Interval 2.917 to 6.033
|
8.000 hours (h)
Interval 2.517 to 12.1
|
—
|
—
|
—
|
—
|
|
Part A: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Tmax of M3
|
5.500 hours (h)
Interval 4.017 to 12.083
|
4.500 hours (h)
Interval 2.983 to 8.0
|
4.500 hours (h)
Interval 2.917 to 6.033
|
6.000 hours (h)
Interval 3.017 to 24.0
|
—
|
—
|
—
|
—
|
|
Part A: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Tmax of Seladelpar
|
1.208 hours (h)
Interval 0.5 to 2.5
|
0.758 hours (h)
Interval 0.5 to 6.0
|
1.250 hours (h)
Interval 0.417 to 3.0
|
1.250 hours (h)
Interval 0.5 to 2.5
|
—
|
—
|
—
|
—
|
|
Part A: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Tmax of M1
|
4.000 hours (h)
Interval 2.417 to 8.0
|
4.500 hours (h)
Interval 2.017 to 6.0
|
3.000 hours (h)
Interval 0.417 to 6.0
|
5.000 hours (h)
Interval 2.517 to 6.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
AUC0-t is defined as area under the concentration--time curve from time zero to the last measurable concentration.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: PK Parameter: AUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-t of Seladelpar
|
800 h*ng/mL
Standard Deviation 214
|
1390 h*ng/mL
Standard Deviation 504
|
1390 h*ng/mL
Standard Deviation 812
|
1970 h*ng/mL
Standard Deviation 416
|
—
|
—
|
—
|
—
|
|
Part A: PK Parameter: AUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-t of M1
|
239 h*ng/mL
Standard Deviation 41.3
|
324 h*ng/mL
Standard Deviation 117
|
351 h*ng/mL
Standard Deviation 151
|
499 h*ng/mL
Standard Deviation 287
|
—
|
—
|
—
|
—
|
|
Part A: PK Parameter: AUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-t of M2
|
2930 h*ng/mL
Standard Deviation 1140
|
3730 h*ng/mL
Standard Deviation 1570
|
4550 h*ng/mL
Standard Deviation 3070
|
4970 h*ng/mL
Standard Deviation 1950
|
—
|
—
|
—
|
—
|
|
Part A: PK Parameter: AUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-t of M3
|
475 h*ng/mL
Standard Deviation 106
|
367 h*ng/mL
Standard Deviation 143
|
394 h*ng/mL
Standard Deviation 75.8
|
368 h*ng/mL
Standard Deviation 171
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
AUC0-inf is defined as area under the concentration--time curve from time zero extrapolated to infinity, calculated as AUC0-t+Ct/Kel, where: Ct = the last measurable concentration and Kel = elimination rate constant.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: PK Parameter: AUC0-inf of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-inf of M3
|
580 h*ng/mL
Standard Deviation 63.8
|
416 h*ng/mL
Standard Deviation 156
|
495 h*ng/mL
Standard Deviation 129
|
404 h*ng/mL
Standard Deviation 99.2
|
—
|
—
|
—
|
—
|
|
Part A: PK Parameter: AUC0-inf of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-inf of Seladelpar
|
841 h*ng/mL
Standard Deviation 228
|
1540 h*ng/mL
Standard Deviation 474
|
1440 h*ng/mL
Standard Deviation 829
|
2020 h*ng/mL
Standard Deviation 443
|
—
|
—
|
—
|
—
|
|
Part A: PK Parameter: AUC0-inf of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-inf of M1
|
272 h*ng/mL
Standard Deviation 44.4
|
339 h*ng/mL
Standard Deviation 122
|
375 h*ng/mL
Standard Deviation 147
|
530 h*ng/mL
Standard Deviation 284
|
—
|
—
|
—
|
—
|
|
Part A: PK Parameter: AUC0-inf of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-inf of M2
|
3140 h*ng/mL
Standard Deviation 1110
|
3930 h*ng/mL
Standard Deviation 1620
|
4660 h*ng/mL
Standard Deviation 3090
|
5270 h*ng/mL
Standard Deviation 2100
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdosePopulation: Participants in the PK Analysis Set were analyzed.
Cmax is defined as the maximum observed plasma concentration of the study drug.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: PK Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Cmax of Seladelpar
|
299.08 ng/mL
Standard Deviation 182.985
|
344.40 ng/mL
Standard Deviation 121.049
|
78.40 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
229.00 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Cmax of M1
|
33.00 ng/mL
Standard Deviation 20.903
|
57.18 ng/mL
Standard Deviation 28.656
|
11.30 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
18.20 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Cmax of M2
|
268.80 ng/mL
Standard Deviation 138.124
|
255.80 ng/mL
Standard Deviation 40.586
|
98.60 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
181.00 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Cmax of M3
|
24.700 ng/mL
Standard Deviation 7.196
|
37.860 ng/mL
Standard Deviation 7.812
|
7.730 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
8.330 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdosePopulation: Participants in the PK Analysis Set were analyzed.
Cmax,ss is defined as the steady-state maximum observed plasma concentration of the study drug at Day 28.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: PK Parameter: Cmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3)
Cmax,ss of Seladelpar
|
260.60 ng/mL
Standard Deviation 75.255
|
324.00 ng/mL
Standard Deviation 153.498
|
53.20 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
255.00 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: Cmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3)
Cmax,ss of M1
|
36.320 ng/mL
Standard Deviation 14.365
|
44.700 ng/mL
Standard Deviation 21.134
|
8.190 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
32.700 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: Cmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3)
Cmax,ss of M2
|
326.2 ng/mL
Standard Deviation 124.20
|
297.2 ng/mL
Standard Deviation 72.77
|
108.0 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
369.0 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: Cmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3)
Cmax,ss of M3
|
36.140 ng/mL
Standard Deviation 15.451
|
48.880 ng/mL
Standard Deviation 18.311
|
8.540 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
18.300 ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdosePopulation: Participants in the PK Analysis Set were analyzed.
Tmax is defined as the time to reach the maximum observed plasma concentration of the study drug.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Tmax of Seladelpar
|
1.000 h
Interval 1.0 to 5.0
|
1.000 h
Interval 0.467 to 2.483
|
1.500 h
Interval 1.5 to 1.5
|
0.500 h
Interval 0.5 to 0.5
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Tmax of M1
|
5.983 h
Interval 2.5 to 8.0
|
2.000 h
Interval 0.467 to 6.0
|
8.000 h
Interval 8.0 to 8.0
|
2.033 h
Interval 2.033 to 2.033
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Tmax of M2
|
5.983 h
Interval 4.0 to 8.0
|
3.500 h
Interval 2.983 to 6.0
|
8.000 h
Interval 8.0 to 8.0
|
6.000 h
Interval 6.0 to 6.0
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Tmax of M3
|
6.000 h
Interval 3.533 to 8.0
|
3.500 h
Interval 3.0 to 6.0
|
12.000 h
Interval 12.0 to 12.0
|
6.000 h
Interval 6.0 to 6.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdosePopulation: Participants in the PK Analysis Set were analyzed.
Tmax,ss is defined as the steady-state time to reach maximum observed plasma concentration of the study drug at Day 28.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: PK Parameter: Tmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3)
Tmax,ss of Seladelpar
|
1.000 h
Interval 0.5 to 2.0
|
0.566 h
Interval 0.5 to 1.5
|
3.500 h
Interval 3.5 to 3.5
|
1.033 h
Interval 1.033 to 1.033
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: Tmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3)
Tmax,ss of M1
|
6.000 h
Interval 2.5 to 8.0
|
3.016 h
Interval 1.0 to 4.0
|
5.000 h
Interval 5.0 to 5.0
|
6.000 h
Interval 6.0 to 6.0
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: Tmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3)
Tmax,ss of M2
|
6.000 h
Interval 2.5 to 8.0
|
3.500 h
Interval 2.5 to 5.9
|
12.000 h
Interval 12.0 to 12.0
|
6.000 h
Interval 6.0 to 6.0
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: Tmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3)
Tmax,ss of M3
|
5.000 h
Interval 4.0 to 8.0
|
4.000 h
Interval 2.5 to 6.0
|
12.000 h
Interval 12.0 to 12.0
|
7.917 h
Interval 7.917 to 7.917
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdosePopulation: Participants in the PK Analysis Set were analyzed.
AUC0-24 is defined as area under the concentration-time curve from time zero to 24 hours.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: PK Parameter: AUC0-24 of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-24 of Seladelpar
|
1450 h*ng/mL
Standard Deviation 548
|
1053 h*ng/mL
Standard Deviation 191
|
814 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
1494 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: AUC0-24 of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-24 of M1
|
346 h*ng/mL
Standard Deviation 183
|
338 h*ng/mL
Standard Deviation 59
|
167 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
209 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: AUC0-24 of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-24 of M2
|
3812 h*ng/mL
Standard Deviation 2315
|
2892 h*ng/mL
Standard Deviation 649
|
1837 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
3219 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: AUC0-24 of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-24 of M3
|
354 h*ng/mL
Standard Deviation 134
|
449 h*ng/mL
Standard Deviation 85
|
141 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
150 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: PK Parameter: AUC0-tau of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-tau of Seladelpar
|
1329 h*ng/mL
Standard Deviation 517
|
1055 h*ng/mL
Standard Deviation 380
|
570 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
1680 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: AUC0-tau of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-tau of M1
|
395 h*ng/mL
Standard Deviation 270
|
339 h*ng/mL
Standard Deviation 121
|
136 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
359 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: AUC0-tau of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-tau of M2
|
4377 h*ng/mL
Standard Deviation 2860
|
3349 h*ng/mL
Standard Deviation 1532
|
2161 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
6415 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: AUC0-tau of Seladelpar and Its Metabolites (M1, M2, and M3)
AUC0-tau of M3
|
461 h*ng/mL
Standard Deviation 308
|
521 h*ng/mL
Standard Deviation 175
|
178 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
307 h*ng/mL
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdosePopulation: Participants in the PK Analysis Set were analyzed.
RCmax is defined as the accumulation ratio based on Cmax, calculated as Cmax on Day 28/ Day 1.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: PK Parameter: RCmax of Seladelpar and Its Metabolites (M1, M2, and M3)
RCmax of Seladelpar
|
1.121 accumulation ratio of Cmax
Standard Deviation 0.657
|
0.940 accumulation ratio of Cmax
Standard Deviation 0.300
|
0.679 accumulation ratio of Cmax
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
1.114 accumulation ratio of Cmax
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: RCmax of Seladelpar and Its Metabolites (M1, M2, and M3)
RCmax of M1
|
1.429 accumulation ratio of Cmax
Standard Deviation 1.056
|
0.906 accumulation ratio of Cmax
Standard Deviation 0.384
|
0.725 accumulation ratio of Cmax
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
1.797 accumulation ratio of Cmax
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: RCmax of Seladelpar and Its Metabolites (M1, M2, and M3)
RCmax of M2
|
1.305 accumulation ratio of Cmax
Standard Deviation 0.332
|
1.158 accumulation ratio of Cmax
Standard Deviation 0.197
|
1.095 accumulation ratio of Cmax
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
2.039 accumulation ratio of Cmax
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: RCmax of Seladelpar and Its Metabolites (M1, M2, and M3)
RCmax of M3
|
1.445 accumulation ratio of Cmax
Standard Deviation 0.274
|
1.264 accumulation ratio of Cmax
Standard Deviation 0.249
|
1.105 accumulation ratio of Cmax
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
2.197 accumulation ratio of Cmax
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdosePopulation: Participants in the PK Analysis Set were analyzed.
RAUC0-t is defined as the accumulation ratio based on AUC0-t, calculated as AUC0-tau on Day 28/ AUC0-24 on Day 1 for participants with dose once a day.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: PK Parameter: RAUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
RAUC0-t of Seladelpar
|
0.957 accumulation ratio of AUC0-t
Standard Deviation 0.258
|
1.014 accumulation ratio of AUC0-t
Standard Deviation 0.275
|
0.700 accumulation ratio of AUC0-t
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
1.124 accumulation ratio of AUC0-t
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: RAUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
RAUC0-t of M1
|
1.130 accumulation ratio of AUC0-t
Standard Deviation 0.383
|
0.999 accumulation ratio of AUC0-t
Standard Deviation 0.286
|
0.811 accumulation ratio of AUC0-t
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
1.720 accumulation ratio of AUC0-t
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: RAUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
RAUC0-t of M2
|
1.222 accumulation ratio of AUC0-t
Standard Deviation 0.521
|
1.145 accumulation ratio of AUC0-t
Standard Deviation 0.392
|
1.176 accumulation ratio of AUC0-t
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
1.993 accumulation ratio of AUC0-t
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
|
Part B: PK Parameter: RAUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
RAUC0-t of M3
|
1.253 accumulation ratio of AUC0-t
Standard Deviation 0.440
|
1.148 accumulation ratio of AUC0-t
Standard Deviation 0.296
|
1.261 accumulation ratio of AUC0-t
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
2.055 accumulation ratio of AUC0-t
Standard Deviation NA
Since only 1 participant was analyzed, standard deviation could not be calculated.
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part A: Up to Week 5; Part B: Up to Week 8Population: The Safety Analysis Set included all study participants who received any amount of seladelpar.
An adverse event (AE) was defined as any medical occurrence in a participant administered to a pharmaceutical product in a clinical study, regardless of a causal relationship with this treatment. TEAEs were defined as AEs that commenced or worsened on or after the time of study drug administration in Part A until up to 30 days after study drug administration in Part A or before the first study drug administration in Part B (whichever is earlier). For Part B, TEAEs are defined as AEs that commence or worsen on or after the time of first study drug administration in Part B until up to 30 days after the last study drug administration in Part B. A drug-related TEAE was defined as TEAE which was related (reported as 'possible', 'probable', or 'definite') to study drug. Percentages were rounded off.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs
Any TEAEs
|
0 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs
Study Drug-Related TEAEs
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
PRIMARY outcome
Timeframe: Part A: Up to Week 5; Part B: Up to Week 8Population: Participants in the Safety Analysis Set were analyzed.
TEAEs severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. Participants were counted at the highest AE grade experienced. The percentage of participants with any severity grade and severity grade of 3 or 4 were reported. Percentages were rounded off.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced Any Grade and Grade 3 or 4 TEAEs
Grade 3 or 4
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Any Grade and Grade 3 or 4 TEAEs
Any Grade
|
0 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
40.0 percentage of participants
|
0 percentage of participants
|
60.0 percentage of participants
|
PRIMARY outcome
Timeframe: Part A: Up to Week 5; Part B: Up to Week 8Population: Participants in the Safety Analysis Set were analyzed.
TEAEs of special interest for this study were defined as AEs that met CTCAE version 5.0 or the most recent version Grade 2 criteria or higher for AEs of elevated alanine transaminase (ALT), aspartate aminotransferase (AST), bilirubin, creatinine kinase, lipase, or serum creatinine. Hepatic decompensation clinical events including ascites, jaundice, esophageal variceal bleeding, and hepatic encephalopathy, were also defined as TEAEs of special interest for this study. Percentages were rounded off.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced TEAEs of Special Interest
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
PRIMARY outcome
Timeframe: Part A: Up to Day 4; Part B: Up to Day 31Population: Participants in the Safety Analysis Set were analyzed.
Vital signs (including oral temperature, respiratory rate, seated blood pressure \[diastolic and systolic\], and heart rate) were evaluated. Percentage of participants with clinically significant changes in vital signs evaluations was reported. The clinically significant changes were based on investigator's judgement.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinically Significant Changes in Vital Signs
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Part A: Up to Day 4; Part B: Up to Day 28Population: Participants in the Safety Analysis Set were analyzed.
ECG measurements included the parameters of heart rate, ventricular rate, PR interval, QRS duration, QT interval (uncorrected), and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Per protocol, ECG findings were classified in 1 of 3 categories: normal, abnormal but not clinically significant, or abnormal and clinically significant. Any abnormality in ECG assessments which were deemed clinically significant by the investigator were reported.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Abnormal Clinically Significant 12-Lead Electrocardiogram (ECG) Findings
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Part A: Up to Day 4; Part B: Up to Day 31Population: Participants in the Safety Analysis Set were analyzed.
Clinical laboratory parameters included biochemistry, hematology, coagulation, and urinalysis. Abnormal laboratory values were graded according to the NCI CTCAE version 5.0.Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Fatal. The percentage of participants with a shift of ≥ 2 NCI CTCAE grade from baseline was reported.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced Laboratory Abnormalities
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0-6 h, and 6-12 h postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Ae0-t is defined as the cumulative urinary excretion from time zero to time t, calculated as the sum of the amounts excreted over each collection interval.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=4 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: PK Parameter (Urine): Ae0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
Ae0-t of Seladelpar
|
1370 ng
Standard Deviation 1020
|
4660 ng
Standard Deviation 3770
|
6460 ng
Standard Deviation 5830
|
3290 ng
Standard Deviation 2940
|
—
|
—
|
—
|
—
|
|
Part A: PK Parameter (Urine): Ae0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
Ae0-t of M1
|
0.513 ng
Standard Deviation 0.634
|
0.957 ng
Standard Deviation 0.352
|
0.976 ng
Standard Deviation 0.675
|
0.503 ng
Standard Deviation 0.261
|
—
|
—
|
—
|
—
|
|
Part A: PK Parameter (Urine): Ae0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
Ae0-t of M2
|
0.119 ng
Standard Deviation 0.089
|
0.363 ng
Standard Deviation 0.462
|
0.345 ng
Standard Deviation 0.314
|
0.056 ng
Standard Deviation 0.059
|
—
|
—
|
—
|
—
|
|
Part A: PK Parameter (Urine): Ae0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
Ae0-t of M3
|
1.17 ng
Standard Deviation 1.01
|
2.24 ng
Standard Deviation 0.694
|
2.41 ng
Standard Deviation 1.94
|
1.04 ng
Standard Deviation 0.474
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0-6 h, and 6-12 h postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
CLR is defined as the renal clearance, calculated as Ae0-t / AUC0-12.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=6 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=5 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=3 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: PK Parameter (Urine): CLR of Seladelpar
|
0.00208 L/h
Standard Deviation 0.001520
|
0.00361 L/h
Standard Deviation 0.002755
|
0.00723 L/h
Standard Deviation 0.007391
|
0.00238 L/h
Standard Deviation 0.002846
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between Cmax and Baseline Albumin.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=24 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Rsq Between Plasma Seladelpar Cmax and Baseline Albumin
|
0.2033 no unit
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-inf and Baseline Albumin.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=24 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Albumin
|
0.3735 no unit
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-t and Baseline Albumin.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=24 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Rsq Between Plasma Seladelpar AUC0-t and Baseline Albumin
|
0.3924 no unit
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between Cmax and Baseline Bilirubin.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=24 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Rsq Between Plasma Seladelpar Cmax and Baseline Bilirubin
|
0.0318 no unit
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-inf and Baseline Bilirubin.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=24 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Bilirubin
|
0.1810 no unit
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-t and Baseline Bilirubin.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=24 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Rsq Between Plasma Seladelpar AUC0-t and Baseline Bilirubin
|
0.2047 no unit
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between Cmax and Baseline Prothrombin Time.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=24 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Rsq Between Plasma Seladelpar Cmax and Baseline Prothrombin Time
|
0.2774 no unit
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-inf and Baseline Prothrombin Time.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=24 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Prothrombin Time
|
0.6014 no unit
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-t and Baseline Prothrombin Time.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=24 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Rsq Between Plasma Seladelpar AUC0-t and Baseline Prothrombin Time
|
0.5804 no unit
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between Cmax and CP score of participants.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=24 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Rsq Between Plasma Seladelpar Cmax and CP Score
|
0.1092 no unit
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-inf and CP score of participants.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=24 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Rsq Between Plasma Seladelpar AUC0-inf and CP Score
|
0.3056 no unit
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-t and CP score of participants.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=24 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Rsq Between Plasma Seladelpar AUC0-t and CP Score
|
0.3250 no unit
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between Cmax and baseline Albumin.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=10 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=2 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Rsq Between Plasma Seladelpar Cmax and Baseline Albumin
|
0.3351 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-t and baseline Albumin.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=10 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=2 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Rsq Between Plasma Seladelpar AUC0-t and Baseline Albumin
Day 1
|
0.0400 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Rsq Between Plasma Seladelpar AUC0-t and Baseline Albumin
Day 28
|
0.1175 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-inf and baseline Albumin.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=10 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=2 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Albumin
|
0.0456 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between Cmax and baseline prothrombin time.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=10 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=2 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Rsq Between Plasma Seladelpar Cmax and Baseline Prothrombin Time
|
0.3124 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-t and baseline prothrombin time.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=10 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=2 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Rsq Between Plasma Seladelpar AUC0-t and Baseline Prothrombin Time
Day 1
|
0.1934 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Rsq Between Plasma Seladelpar AUC0-t and Baseline Prothrombin Time
Day 28
|
0.3108 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-inf and baseline prothrombin time.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=10 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=2 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Prothrombin Time
|
0.2020 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between Cmax and baseline bilirubin.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=10 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=2 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Rsq Between Plasma Seladelpar Cmax and Baseline Bilirubin
|
0.0012 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-t and baseline bilirubin.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=10 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=2 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Rsq Between Plasma Seladelpar AUC0-t and Baseline Bilirubin
Day 1
|
0.1136 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Rsq Between Plasma Seladelpar AUC0-t and Baseline Bilirubin
Day 28
|
0.0805 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-inf and baseline bilirubin.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=10 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=2 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Bilirubin
|
0.0993 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between Cmax and CP score of participants.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=10 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=2 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Rsq Between Plasma Seladelpar Cmax and CP Score
|
0.0118 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose; Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-t and and CP score of participants.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=10 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=2 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Rsq Between Plasma Seladelpar AUC0-t and CP Score
Day 1
|
0.2036 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Rsq Between Plasma Seladelpar AUC0-t and CP Score
Day 28
|
0.1912 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdosePopulation: Participants in the PK Analysis Set with available data were analyzed.
Rsq is defined as the R-squared value for the regression between AUC0-inf and and CP score of participants.
Outcome measures
| Measure |
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=10 Participants
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=2 Participants
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Rsq Between Plasma Seladelpar AUC0-inf and CP Score
|
0.1901 no unit
|
NA no unit
R-squared value was not estimable due to low number of participants available for regression analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: Cohort 3 - CP-B (Seladelpar 10 mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A: Cohort 4 - CP-C (Seladelpar 10 mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg)
n=6 participants at risk
Participants with PBC and a CP classification of CP-A (score 5 to 6) without PHT, received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Part A: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=6 participants at risk
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Part A: Cohort 3 - CP-B (Seladelpar 10 mg)
n=6 participants at risk
Participants with PBC and a CP classification of CP-B (score 7 to 9), received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Part A: Cohort 4 - CP-C (Seladelpar 10 mg)
n=6 participants at risk
Participants with PBC and a CP classification of CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 participants at risk
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 participants at risk
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 participants at risk
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 participants at risk
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Generalised oedema
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
Other adverse events
| Measure |
Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg)
n=6 participants at risk
Participants with PBC and a CP classification of CP-A (score 5 to 6) without PHT, received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Part A: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=6 participants at risk
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Part A: Cohort 3 - CP-B (Seladelpar 10 mg)
n=6 participants at risk
Participants with PBC and a CP classification of CP-B (score 7 to 9), received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Part A: Cohort 4 - CP-C (Seladelpar 10 mg)
n=6 participants at risk
Participants with PBC and a CP classification of CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg)
n=1 participants at risk
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 2 - CP-A With PHT (Seladelpar 10 mg)
n=5 participants at risk
Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 5 mg)
n=1 participants at risk
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
Part B: Cohort 3 - CP-B (Seladelpar 10 mg)
n=5 participants at risk
Participants with PBC and a CP classification of CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. Dose for Part B was chosen based on exposure from a single dose in Part A for individual participants.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
16.7%
1/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
16.7%
1/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
16.7%
1/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Investigations
Bone density decreased
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/6 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
20.0%
1/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/1 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
0.00%
0/5 • All-cause Mortality: Up to 31 weeks; Adverse Events: Part A: Up to Week 5; Part B: Up to Week 8
All-cause Mortality: The All Enrolled Analysis Set included all enrolled participants. Adverse Events: The Safety Analysis Set included all study participants who received any amount of seladelpar.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER