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

NCT ID: NCT04950764

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-17
• Study Completion Date: 2025-02-27

Brief 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)

Conditions

Primary Biliary Cholangitis; Compensated Cirrhosis; Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Seladelpar 10 mg

Part A: Single oral dose 10 mg

Group Type: EXPERIMENTAL

Seladelpar 10 mg

Intervention Type: DRUG

Seladelpar 10 mg single oral dose

Seladelpar 10 mg or less

Part B: Multiple oral dose of 10 mg or less

Group Type: EXPERIMENTAL

Seladelpar 10 mg or less

Intervention Type: DRUG

Seladelpar 10 mg or less, once daily for 28 days

Interventions

Seladelpar 10 mg

Seladelpar 10 mg single oral dose

Intervention Type: DRUG

Seladelpar 10 mg or less

Seladelpar 10 mg or less, once daily for 28 days

Intervention Type: DRUG

Other Intervention Names

Livdelzi®; Livdelzi®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Arizona Liver Health

Chandler, Arizona, United States

University of California Davis

Sacramento, California, United States

University of Colorado Anschutz

Aurora, Colorado, United States

Mercy Medical Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Health System

Novi, Michigan, United States

Southern Therapy and Advanced Research LLC

Jackson, Mississippi, United States

Weill Medical College of Cornell University

New York, New York, United States

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, United States

American Research Corporation

San Antonio, Texas, United States

Pinnacle Clinical Research- SA

San Antonio, Texas, United States

Pusan National University Hospital

Busan, , South Korea

Inje University Busan Paik Hospital

Busan, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Hospital General Universitario Gregorio Maran

Madrid, , Spain

NIHR BRC Centre for Liver and Gastrointestinal Research Birmingham

Birmingham, , United Kingdom

The Royal Free London NHS Foundation Trust

London, , United Kingdom

Kings College Hospital

London, , United Kingdom

Countries

United States; South Korea; Spain; United Kingdom

Other Identifiers

2020-005925-10

Identifier Type: OTHER

Identifier Source: secondary_id

CB8025-21838

Identifier Type: -

Identifier Source: org_study_id