An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)

The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Participants with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment; Compensated Cirrhosis; Primary Biliary Cholangitis
• Intervention / Treatment: Drug: Seladelpar

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Busan, South Korea, 49241
    • Pusan National University Hospital
  • Busan, South Korea
    • Inje University Busan Paik Hospital
  • Daegu, South Korea, 41944
    • Kyungpook National University Hospital
  • Seoul, South Korea, 3080
    • Seoul National University Hospital
  • Seoul, South Korea, 3722
    • Severance Hospital Yonsei University Health System
• Spain
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maran
• United Kingdom
  • Birmingham, United Kingdom, B15 2GW
    • NIHR BRC Centre for Liver and Gastrointestinal Research Birmingham
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • London, United Kingdom, NW2 2QG
    • The Royal Free London NHS Foundation Trust
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona Liver Health
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Novi, Michigan, United States, 48377
      • Henry Ford Health System
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Southern Therapy and Advanced Research LLC
  • New York
    • New York, New York, United States, 10021
      • Weill Medical College of Cornell University
  • Texas
    • Dallas, Texas, United States, 75203
      • The Liver Institute at Methodist Dallas Medical Center
    • San Antonio, Texas, United States, 78215
      • American Research Corporation
    • San Antonio, Texas, United States, 78229
      • Pinnacle Clinical Research- SA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males and females between 18 and 80 years of age (inclusive) who are able to comprehend instructions and follow the study procedures and are willing to sign an Informed Consent Form (ICF)
2. Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized since at least 6 months) must be willing to use the contraceptive methods throughout the study and for 30 days after study drug administration.
3. For at least 90 days after study drug administration, non-vasectomized males must not donate sperm, be willing to use contraception with childbearing potential partners and any male participant with a pregnant partner must use a condom.
4. Willing to abstain from consuming grapefruit, pomelo, star fruit, or Seville orange containing products from 7 days prior to dose of study medication through day of discharge.
5. Confirmed diagnosis of PBC with evidence of cirrhosis and Child-Pugh classification of CP-A, CP-A + PHT, CP-B or CP-C

6. Screening laboratory parameters:

   • Alkaline phosphatase (ALP), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 10 × upper Limit of normal (ULN)
   • Total bilirubin ≤ 5 × ULN
7. Ursodeoxycholic acid (UDCA) for a minimum of 12 weeks of treatment prior to Day 1
8. At screening confirmed diagnosis of PBC
9. Model for end-stage liver disease (MELD)-Na scores of 6 to 24

Exclusion Criteria:

1. Clinically significant or history of acute or chronic liver disease of an etiology other than PBC
2. Patients with a diagnosis of overlapping PBC and autoimmune hepatitis
3. History, evidence, or high suspicion of hepatobiliary malignancy based on imaging, screening laboratory values, and/or clinical symptoms.
4. Presumptive or diagnosed infection that requires systemic therapy within 12 weeks of Screening and through Day 1
5. Female participants who are pregnant or nursing
6. Screening electrocardiogram (ECG) that demonstrates a QT interval ≥ 500 msec, or any other significant ECG finding with clinically significant abnormalities as determined by the Investigator
7. Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus - ribonucleic acid (HCV RNA), or anti human immunodeficiency virus (HIV) antibody
8. Any non-hepatic acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in the study or compromise the integrity of the data
9. Has experienced an illness that is considered by the Investigator to be clinically significant within 2 weeks before administration of investigational product
10. Clinically relevant drug or alcohol abuse within 6 months of Screening. A positive drug screen will exclude participants unless it can be explained by a prescribed medication
11. Use of obeticholic acid (OCA), any drug of the same class, or fibrates (e.g., bezafibrate, fenofibrate, elafibranor, lanifibranor, pemafibrate, saroglitizar) within 30 days of Baseline
12. Use of an experimental or unapproved treatment for PBC within 30 days of Baseline
13. Clinically evident complication(s) of cirrhosis and portal hypertension that required either emergency room visit, hospital admission or both during the 12 week period prior to investigational product administration

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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) will receive a single dose of seladelpar 10 mg, orally, on Day 1.	Drug: Seladelpar; Tablets Administered Orally; Other Names: Livdelzi®
Experimental: 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 will receive a single dose of seladelpar 10 mg, orally, on Day 1.	Drug: Seladelpar; Tablets Administered Orally; Other Names: Livdelzi®
Experimental: Part A: Cohort 3 - CP-B (Seladelpar 10 mg); Participants with PBC and a CP classification of CP-B (score 7 to 9) will receive a single dose of seladelpar 10 mg, orally, on Day 1.	Drug: Seladelpar; Tablets Administered Orally; Other Names: Livdelzi®
Experimental: Part A: Cohort 4 - CP-C (Seladelpar 10 mg); Participants with PBC and a CP classification of CP-C (score 10 to 12) will receive a single dose of seladelpar 10 mg, orally, on Day 1.	Drug: Seladelpar; Tablets Administered Orally; Other Names: Livdelzi®
Experimental: Experimental: Part B: Cohort 2 - CP-A With PHT (Seladelpar 5 mg or 10 mg); Participants with PBC and a CP classification of CP-A (score 5 to 6) with PHT, who complete Part A, will receive seladelpar 10 mg or 5 mg, orally, once daily, for 28 days. Doses for Part B will be chosen based on exposure from a single dose in Part A for individual participants.	Drug: Seladelpar; Tablets Administered Orally; Other Names: Livdelzi®
Experimental: Experimental: Part B: Cohort 3 - CP-B (Seladelpar 5 mg or 10 mg); Participants with PBC and a CP classification of CP-B (score 7 to 9), who complete Part A, will receive seladelpar 10 mg or 5 mg, orally, once daily, for 28 days. Doses for Part B will be chosen based on exposure from a single dose in Part A for individual participants.	Drug: Seladelpar; Tablets Administered Orally; Other Names: Livdelzi®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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
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.	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
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.	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
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.	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
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.	Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
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.	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
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.	Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
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.	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
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.	Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
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.	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
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.	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
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.	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
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.	Part A: Up to Week 5; Part B: Up to Week 8
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.	Part A: Up to Week 5; Part B: Up to Week 8
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.	Part A: Up to Week 5; Part B: Up to Week 8
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.	Part A: Up to Day 4; Part B: Up to Day 31
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.	Part A: Up to Day 4; Part B: Up to Day 28
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.	Part A: Up to Day 4; Part B: Up to Day 31

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1: Predose; 0-6 h, and 6-12 h postdose
Part A: PK Parameter (Urine): CLR of Seladelpar	CLR is defined as the renal clearance, calculated as Ae0-t / AUC0-12.	Day 1: Predose; 0-6 h, and 6-12 h postdose
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.	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
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.	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
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.	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
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.	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
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.	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
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.	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
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.	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
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.	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
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.	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
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.	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
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.	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
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.	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
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.	Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
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.	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
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.	Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
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.	Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
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.	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
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.	Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
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.	Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
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.	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
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.	Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
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.	Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose
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.	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
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.	Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): February 24, 2025
• Study Completion (Actual): February 27, 2025

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PBC; Primary Biliary Cholangitis (PBC)
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Biliary Tract Diseases; Liver Diseases; Bile Duct Diseases; Fibrosis; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Pathological Conditions, Signs and Symptoms; Liver Cirrhosis, Biliary; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; seladelpar
• Other Study ID Numbers: CB8025-21838; 2020-005925-10 (EudraCT Number: EU Trial (CTIS) Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified external researchers may request IPD for this study. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
• IPD Sharing Time Frame: 18 months after study completion and at least 6 months after the FDA and EMA approval
• IPD Sharing Access Criteria: A secured external environment with username, password, and RSA code.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No