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NCT04950764 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT04950764: Completed Phase 1 study, sponsored by Gilead Sciences.

NCT04950764 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04950764, a Phase 1 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study 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)

Primary Outcome

Cmax is defined as the maximum observed plasma concentration of the study drug.

Interventions

  • DRUG Seladelpar

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2021-11-16
Est. Completion 2025-02-27
Phase Phase 1
Gilead Sciences

504 total trials

What the finished NCT04950764 record still lists

NCT04950764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 1 intervention - of which Seladelpar is the first listed.

NCT04950764 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04950764 about?

NCT04950764 is a clinical study titled "An Open-Label Study Following Oral Dosing of Seladelpar to Participants 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 Participants with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)

What is the current status of trial NCT04950764?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-11-16. Estimated completion is 2025-02-27.

What interventions are being tested in trial NCT04950764?

The interventions under investigation include: Seladelpar (DRUG).

Who is sponsoring clinical trial NCT04950764?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04950764's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04950764, the US trial registry maintained by the National Library of Medicine. NCT04950764 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.