LAST UPDATED
May 04, 2026
Clinicaltrials.gov ID
EudraCT ID
OVERVIEW
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
PROTOCOL SUMMARY
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)
View moreParticipation requirements
Age
18 years - 80 years
Sex
All
Healthy Volunteers
No
Age
18 years - 80 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Primary Biliary Cholangitis, Compensated Cirrhosis, Hepatic Impairment
Gender
N/A
Date
November 2021 - February 2025
Study Type
Interventional
Study Phase
Phase 1
Product
Seladelpar
Eligibility information
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.
Locations
Locations (20)
University of California Davis
Sacramento, California, United States, 95817
University of Colorado Anschutz
Aurora, Colorado, United States, 80045
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Southern Therapy and Advanced Research LLC
Jackson, Mississippi, United States, 39216
Weill Medical College of Cornell University
New York, New York, United States, 10021
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
American Research Corporation
San Antonio, Texas, United States, 78215
Pinnacle Clinical Research- SA
San Antonio, Texas, United States, 78229
Severance Hospital Yonsei University Health System
Seoul, South Korea, 3722
NIHR BRC Centre for Liver and Gastrointestinal Research Birmingham
Birmingham, United Kingdom, B15 2GW
The Royal Free London NHS Foundation Trust
London, United Kingdom, NW2 2QG
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