| Primary | Part A: Pharmacokinetic (PK) Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3) | Cmax is defined as the maximum observed plasma concentration of the study drug. | 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. | Posted | | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
| | | Title | Denominators | Categories |
|---|
| Cmax of Seladelpar | | | Title | Measurements |
|---|
| - OG000182.0± 60.68
- OG001367.7± 238.28
- OG002359.2± 158.61
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Statistical Analysis of Plasma Seladelpar PK Parameter (Cmax) | | | | | Geometric Least-squares Mean Ratio | 183 | | | 2-Sided | 90 | 114 | 295 | | | Estimated ratio of model-adjusted geometric means was used to perform comparison. A linear model was fit to the data per parameter. The response variable was the natural-log transformed PK parameter, and the model included cohort as fixed effect. | | Other | | | |
|
| Primary | Part A: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3) | Tmax is defined as the time to reach the maximum observed plasma concentration of the study drug. | Participants in the PK Analysis Set were analyzed. | Posted | | Median | Full Range | hours (h) | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part A: Cohort 4 - CP-C (Seladelpar 10 mg) |
|
| Primary | Part A: PK Parameter: AUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3) | AUC0-t is defined as area under the concentration--time curve from time zero to the last measurable concentration. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part A: Cohort 4 - CP-C (Seladelpar 10 mg) |
|
| Primary | Part A: PK Parameter: AUC0-inf of Seladelpar and Its Metabolites (M1, M2, and M3) | 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. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| Primary | Part B: PK Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3) | Cmax is defined as the maximum observed plasma concentration of the study drug. | Participants in the PK Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Part B: PK Parameter: Cmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3) | Cmax,ss is defined as the steady-state maximum observed plasma concentration of the study drug at Day 28. | Participants in the PK Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | ng/mL | | Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Part B: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3) | Tmax is defined as the time to reach the maximum observed plasma concentration of the study drug. | Participants in the PK Analysis Set were analyzed. | Posted | | Median | Full Range | h | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Part B: PK Parameter: Tmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3) | Tmax,ss is defined as the steady-state time to reach maximum observed plasma concentration of the study drug at Day 28. | Participants in the PK Analysis Set were analyzed. | Posted | | Median | Full Range | h | | Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Part B: PK Parameter: AUC0-24 of Seladelpar and Its Metabolites (M1, M2, and M3) | AUC0-24 is defined as area under the concentration-time curve from time zero to 24 hours. | Participants in the PK Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Part B: PK Parameter: AUC0-tau of Seladelpar and Its Metabolites (M1, M2, and M3) | AUCtau is defined as the area under the drug concentration versus time curve over the dosing interval. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | h*ng/mL | | Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Part B: PK Parameter: RCmax of Seladelpar and Its Metabolites (M1, M2, and M3) | RCmax is defined as the accumulation ratio based on Cmax, calculated as Cmax on Day 28/ Day 1. | Participants in the PK Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | accumulation ratio of Cmax | | Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Part B: PK Parameter: RAUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3) | 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. | Participants in the PK Analysis Set were analyzed. | Posted | | Mean | Standard Deviation | accumulation ratio of AUC0-t | | Day 28: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) and Study Drug-Related TEAEs | 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. | The Safety Analysis Set included all study participants who received any amount of seladelpar. | Posted | | Number | | percentage of participants | | Part A: Up to Week 5; Part B: Up to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 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. | | OG001 | 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. |
|
| Primary | Percentage of Participants Who Experienced Any Grade and Grade 3 or 4 TEAEs | 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. | Participants in the Safety Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Part A: Up to Week 5; Part B: Up to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Percentage of Participants Who Experienced TEAEs of Special Interest | 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. | Participants in the Safety Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Part A: Up to Week 5; Part B: Up to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Percentage of Participants With Clinically Significant Changes in Vital Signs | 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. | Participants in the Safety Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Part A: Up to Day 4; Part B: Up to Day 31 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Percentage of Participants With Abnormal Clinically Significant 12-Lead Electrocardiogram (ECG) Findings | 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. | Participants in the Safety Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Part A: Up to Day 4; Part B: Up to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 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. | | OG001 | 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. | | OG002 | Part A: Cohort 3 - CP-B (Seladelpar 10 mg) | |
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| Primary | Percentage of Participants Who Experienced Laboratory Abnormalities | 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. | Participants in the Safety Analysis Set were analyzed. | Posted | | Number | | percentage of participants | | Part A: Up to Day 4; Part B: Up to Day 31 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Part A: PK Parameter (Urine): Ae0-t of Seladelpar and Its Metabolites (M1, M2, and M3) | 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. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ng | | Day 1: Predose; 0-6 h, and 6-12 h postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part A: Cohort 4 - CP-C (Seladelpar 10 mg) |
|
| Secondary | Part A: PK Parameter (Urine): CLR of Seladelpar | CLR is defined as the renal clearance, calculated as Ae0-t / AUC0-12. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | L/h | | Day 1: Predose; 0-6 h, and 6-12 h postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
|
| Secondary | Part A: Rsq Between Plasma Seladelpar Cmax and Baseline Albumin | Rsq is defined as the R-squared value for the regression between Cmax and Baseline Albumin. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) without PHT, CP-A (score 5 to 6) with PHT, CP-B (score 7 to 9), and CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1. |
| |
| Secondary | Part A: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Albumin | Rsq is defined as the R-squared value for the regression between AUC0-inf and Baseline Albumin. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) without PHT, CP-A (score 5 to 6) with PHT, CP-B (score 7 to 9), and CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1. |
| |
| Secondary | Part A: Rsq Between Plasma Seladelpar AUC0-t and Baseline Albumin | Rsq is defined as the R-squared value for the regression between AUC0-t and Baseline Albumin. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) without PHT, CP-A (score 5 to 6) with PHT, CP-B (score 7 to 9), and CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1. |
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| Secondary | Part A: Rsq Between Plasma Seladelpar Cmax and Baseline Bilirubin | Rsq is defined as the R-squared value for the regression between Cmax and Baseline Bilirubin. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) without PHT, CP-A (score 5 to 6) with PHT, CP-B (score 7 to 9), and CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1. |
| |
| Secondary | Part A: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Bilirubin | Rsq is defined as the R-squared value for the regression between AUC0-inf and Baseline Bilirubin. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) without PHT, CP-A (score 5 to 6) with PHT, CP-B (score 7 to 9), and CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1. |
| |
| Secondary | Part A: Rsq Between Plasma Seladelpar AUC0-t and Baseline Bilirubin | Rsq is defined as the R-squared value for the regression between AUC0-t and Baseline Bilirubin. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) without PHT, CP-A (score 5 to 6) with PHT, CP-B (score 7 to 9), and CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1. |
| |
| Secondary | Part A: Rsq Between Plasma Seladelpar Cmax and Baseline Prothrombin Time | Rsq is defined as the R-squared value for the regression between Cmax and Baseline Prothrombin Time. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) without PHT, CP-A (score 5 to 6) with PHT, CP-B (score 7 to 9), and CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1. |
| |
| Secondary | Part A: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Prothrombin Time | Rsq is defined as the R-squared value for the regression between AUC0-inf and Baseline Prothrombin Time. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) without PHT, CP-A (score 5 to 6) with PHT, CP-B (score 7 to 9), and CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1. |
| |
| Secondary | Part A: Rsq Between Plasma Seladelpar AUC0-t and Baseline Prothrombin Time | Rsq is defined as the R-squared value for the regression between AUC0-t and Baseline Prothrombin Time. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) without PHT, CP-A (score 5 to 6) with PHT, CP-B (score 7 to 9), and CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1. |
| |
| Secondary | Part A: Rsq Between Plasma Seladelpar Cmax and CP Score | Rsq is defined as the R-squared value for the regression between Cmax and CP score of participants. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) without PHT, CP-A (score 5 to 6) with PHT, CP-B (score 7 to 9), and CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1. |
| |
| Secondary | Part A: Rsq Between Plasma Seladelpar AUC0-inf and CP Score | Rsq is defined as the R-squared value for the regression between AUC0-inf and CP score of participants. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) without PHT, CP-A (score 5 to 6) with PHT, CP-B (score 7 to 9), and CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1. |
| |
| Secondary | Part A: Rsq Between Plasma Seladelpar AUC0-t and CP Score | Rsq is defined as the R-squared value for the regression between AUC0-t and CP score of participants. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part A: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) without PHT, CP-A (score 5 to 6) with PHT, CP-B (score 7 to 9), and CP-C (score 10 to 12), received a single dose of seladelpar 10 mg, orally, on Day 1. |
| |
| Secondary | Part B: Rsq Between Plasma Seladelpar Cmax and Baseline Albumin | Rsq is defined as the R-squared value for the regression between Cmax and baseline Albumin. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part B: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. | | OG001 | Part B: Seladelpar 5 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. |
| |
| Secondary | Part B: Rsq Between Plasma Seladelpar AUC0-t and Baseline Albumin | Rsq is defined as the R-squared value for the regression between AUC0-t and baseline Albumin. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | 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 postdose | | | | ID | Title | Description |
|---|
| OG000 | Part B: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. | | OG001 | Part B: Seladelpar 5 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. |
| |
| Secondary | Part B: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Albumin | Rsq is defined as the R-squared value for the regression between AUC0-inf and baseline Albumin. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part B: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. | | OG001 | Part B: Seladelpar 5 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. |
| |
| Secondary | Part B: Rsq Between Plasma Seladelpar Cmax and Baseline Prothrombin Time | Rsq is defined as the R-squared value for the regression between Cmax and baseline prothrombin time. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part B: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. | | OG001 | Part B: Seladelpar 5 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. |
| |
| Secondary | Part B: Rsq Between Plasma Seladelpar AUC0-t and Baseline Prothrombin Time | Rsq is defined as the R-squared value for the regression between AUC0-t and baseline prothrombin time. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | 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 postdose | | | | ID | Title | Description |
|---|
| OG000 | Part B: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. | | OG001 | Part B: Seladelpar 5 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. |
| |
| Secondary | Part B: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Prothrombin Time | Rsq is defined as the R-squared value for the regression between AUC0-inf and baseline prothrombin time. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part B: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. | | OG001 | Part B: Seladelpar 5 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. |
| |
| Secondary | Part B: Rsq Between Plasma Seladelpar Cmax and Baseline Bilirubin | Rsq is defined as the R-squared value for the regression between Cmax and baseline bilirubin. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part B: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. | | OG001 | Part B: Seladelpar 5 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. |
| |
| Secondary | Part B: Rsq Between Plasma Seladelpar AUC0-t and Baseline Bilirubin | Rsq is defined as the R-squared value for the regression between AUC0-t and baseline bilirubin. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | 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 postdose | | | | ID | Title | Description |
|---|
| OG000 | Part B: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. | | OG001 | Part B: Seladelpar 5 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. |
| |
| Secondary | Part B: Rsq Between Plasma Seladelpar AUC0-inf and Baseline Bilirubin | Rsq is defined as the R-squared value for the regression between AUC0-inf and baseline bilirubin. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part B: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. | | OG001 | Part B: Seladelpar 5 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. |
| |
| Secondary | Part B: Rsq Between Plasma Seladelpar Cmax and CP Score | Rsq is defined as the R-squared value for the regression between Cmax and CP score of participants. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part B: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. | | OG001 | Part B: Seladelpar 5 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. |
| |
| Secondary | Part B: Rsq Between Plasma Seladelpar AUC0-t and CP Score | Rsq is defined as the R-squared value for the regression between AUC0-t and and CP score of participants. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | 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 postdose | | | | ID | Title | Description |
|---|
| OG000 | Part B: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. | | OG001 | Part B: Seladelpar 5 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. |
| |
| Secondary | Part B: Rsq Between Plasma Seladelpar AUC0-inf and CP Score | Rsq is defined as the R-squared value for the regression between AUC0-inf and and CP score of participants. | Participants in the PK Analysis Set with available data were analyzed. | Posted | | Number | | no unit | | Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Part B: Seladelpar 10 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 10 mg, orally, once daily, for 28 days. | | OG001 | Part B: Seladelpar 5 mg | Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT or CP-B (score 7 to 9), who completed Part A, received seladelpar 5 mg, orally, once daily, for 28 days. |
| |