CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Seladelpardrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04950764
NCT04950764Phase 1Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Jul 6, 2021·Updated May 4, 2026

In Brief

A Phase 1 clinical trial evaluating Seladelpar for Primary Biliary Cholangitis and 2 related conditions. Completed, enrolled 24 participants across 20 sites in 4 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Biliary Cholangitis, Compensated Cirrhosis, Hepatic Impairment
CountriesSouth Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedJul 6, 2021
Enrollment StartNov 16, 2021
Primary CompletionFeb 24, 2025
Study CompletionFeb 27, 2025
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.0 years ago

Interventions

Seladelpardrug

Tablets Administered Orally