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

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 17, 2021

Primary Completion Date

February 24, 2025

Study Completion Date

February 27, 2025

Conditions
Primary Biliary CholangitisCompensated CirrhosisHepatic Impairment
Interventions
DRUG

Seladelpar 10 mg

Seladelpar 10 mg single oral dose

DRUG

Seladelpar 10 mg or less

Seladelpar 10 mg or less, once daily for 28 days

Trial Locations (20)

3080

Seoul National University Hospital, Seoul

3722

Severance Hospital Yonsei University Health System, Seoul

10021

Weill Medical College of Cornell University, New York

21202

Mercy Medical Center, Baltimore

28007

Hospital General Universitario Gregorio Maran, Madrid

39216

Southern Therapy and Advanced Research LLC, Jackson

41944

Kyungpook National University Hospital, Daegu

48377

Henry Ford Health System, Novi

49241

Pusan National University Hospital, Busan

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

78215

American Research Corporation, San Antonio

78229

Pinnacle Clinical Research- SA, San Antonio

80045

University of Colorado Anschutz, Aurora

85224

Arizona Liver Health, Chandler

95817

University of California Davis, Sacramento

02114

Massachusetts General Hospital, Boston

Unknown

Inje University Busan Paik Hospital, Busan

B15 2GW

NIHR BRC Centre for Liver and Gastrointestinal Research Birmingham, Birmingham

NW2 2QG

The Royal Free London NHS Foundation Trust, London

SE5 9RS

Kings College Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT04950764 - An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) | Biotech Hunter | Biotech Hunter