Study Details

PROTOCOL SUMMARY

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 (HI)

Participation Requirements

Age

18 Years - 80 Years

Sex

ALL

Healthy Volunteers

Medical Condition

Primary Biliary Cholangitis, Compensated Cirrhosis, Hepatic Impairment

Gender

N/A

Date

September 2021 - February 2025

Study Type

INTERVENTIONAL

Study Phase

PHASE1

Product

Seladelpar 10 mg, Seladelpar 10 mg or less

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 subject 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:
ALP, ALT and AST < 10 × 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. 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 subjects who are pregnant or nursing
6. Screening 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 HBsAg, HCV RNA, or anti 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 subjects 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

Locations

Locations (20)

Arizona Liver Health

Chandler, Arizona, United States, 85224

University of California Davis

Sacramento, California, United States, 95817

University of Colorado Anschutz

Aurora, Colorado, United States, 80045

Mercy Medical Center

Baltimore, Maryland, United States, 21202

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Henry Ford Health System

Novi, Michigan, United States, 48377

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

Pusan National University Hospital

Busan, South Korea, 49241

Inje University Busan Paik Hospital

Busan, South Korea

Kyungpook National University Hospital

Daegu, South Korea, 41944

Seoul National University Hospital

Seoul, South Korea, 3080

Severance Hospital Yonsei University Health System

Seoul, South Korea, 3722

Hospital General Universitario Gregorio Maran

Madrid, Spain, 28007

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

Kings College Hospital

London, United Kingdom, SE5 9RS

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

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