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

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NCT04950764 · results posted

Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.

Phase

Phase 1

Status

Completed

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

24actual

Sites

Countries

South Korea, Spain, United Kingdom +1

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2021-11-16

actual

When the study began enrolling

Primary completion

2025-02-24

actual

The date the last participant is measured for the primary outcome — the readout window

Study completion

2025-02-27

actual

The whole study's end, after follow-up

First posted

2021-07-06

actual

When this record first appeared on the registry

Results posted

2026-05-04

actual

When the sponsor posted results to the registry

Record updated

2026-05-04

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Primary Biliary Cholangitis
Compensated Cirrhosis
Hepatic Impairment

Intervention

Drug: Seladelpar — also filed as Livdelzi®

Primary outcomes

what the primary-completion date above is the date OF

Part A: Pharmacokinetic (PK) Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)

measured Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose

Part A: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3)

measured Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose

Part A: PK Parameter: AUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3)

measured Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose

Part A: PK Parameter: AUC0-inf of Seladelpar and Its Metabolites (M1, M2, and M3)

measured Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose

Part B: PK Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)

measured Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours postdose

Part B: PK Parameter: Cmax,ss of Seladelpar and Its Metabolites (M1, M2, and M3)