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NCT03369002 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects
A Phase 1 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT03369002 is a Phase 1 study that has completed, run by Gilead Sciences. The registered enrollment target is 32 participants.
The verdict
NCT03369002, a Phase 1 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function.
Interventions
- DRUG seladelpar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2018-05-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03369002
The ClinicalTrials.gov registry entry for NCT03369002 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which seladelpar is the first listed.
NCT03369002 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03369002 about?
NCT03369002 is a clinical study titled "Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects". This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic functi...
What is the current status of trial NCT03369002?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2017-11-27. Estimated completion is 2018-05-15.
What interventions are being tested in trial NCT03369002?
The interventions under investigation include: seladelpar (DRUG).
Who is sponsoring clinical trial NCT03369002?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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