Completed PHASE1 INTERVENTIONAL 2-arm NCT04950764

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

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

Sponsor: Gilead Sciences

Conditions Compensated Cirrhosis Hepatic Impairment Primary Biliary Cholangitis

Interventions Seladelpar 10 mg Seladelpar 10 mg or less

Updated 22 times since 2021 Last updated: Mar 14, 2025 Started: Sep 17, 2021 Primary completion: Feb 24, 2025 Completion: Feb 27, 2025

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04950764, this PHASE1 trial focuses on Compensated Cirrhosis and Hepatic Impairment and remains completed. Sponsored by Gilead Sciences, it has been updated 22 times since 2021, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

22 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE1
Apr 2025 — Sep 2025 [monthly]

Completed PHASE1

Status: Recruiting → Completed
Dec 2024 — Apr 2025 [monthly]

Recruiting PHASE1
Nov 2024 — Dec 2024 [monthly]

Recruiting PHASE1
Oct 2024 — Nov 2024 [monthly]

Recruiting PHASE1

▶ Show 17 earlier versions

Sep 2024 — Oct 2024 [monthly]

Recruiting PHASE1
Aug 2024 — Sep 2024 [monthly]

Recruiting PHASE1
Jul 2024 — Aug 2024 [monthly]

Recruiting PHASE1
Feb 2024 — Jul 2024 [monthly]

Recruiting PHASE1
May 2023 — Feb 2024 [monthly]

Recruiting PHASE1
Apr 2023 — May 2023 [monthly]

Recruiting PHASE1
Feb 2023 — Apr 2023 [monthly]

Recruiting PHASE1
Jan 2023 — Feb 2023 [monthly]

Recruiting PHASE1
Sep 2022 — Jan 2023 [monthly]

Recruiting PHASE1
Jul 2022 — Sep 2022 [monthly]

Recruiting PHASE1
Jun 2022 — Jul 2022 [monthly]

Recruiting PHASE1
Apr 2022 — Jun 2022 [monthly]

Recruiting PHASE1
Feb 2022 — Apr 2022 [monthly]

Recruiting PHASE1
Jan 2022 — Feb 2022 [monthly]

Recruiting PHASE1
Dec 2021 — Jan 2022 [monthly]

Recruiting PHASE1
Nov 2021 — Dec 2021 [monthly]

Recruiting PHASE1

Status: Not Yet Recruiting → Recruiting
Sep 2021 — Nov 2021 [monthly]

Not Yet Recruiting PHASE1

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Gilead Sciences

Data source: Gilead Sciences

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aurora, United States , Baltimore, United States , Birmingham, United Kingdom , Boston, United States , Busan, South Korea , Chandler, United States , Daegu, South Korea , Dallas, United States , Jackson, United States , London, United Kingdom and 6 more locations