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NCT06908954 · ClinicalTrials.gov registry record · Phase 1
A Study of the Blood Levels of Palovarotene in Participants With Abnormal Liver Function Compared to Healthy Adult Participants After Intake of a Single Dose
A Phase 1 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT06908954 is a Phase 1 study that has completed, run by Ipsen. The registered enrollment target is 31 participants.
The verdict
NCT06908954, a Phase 1 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The main aim of this study is to understand how moderate and severe liver impairment (based on the Child-Pugh classification) affects the body's processing of a single dose of 10 mg maximum of palovarotene, compared to healthy participants with normal liver function. The study will also assess the safety and tolerability of the single dose of palovarotene. Participants will be enrolled in stages and divided into three groups based on their liver function: * Group 1: Healthy participants with normal liver function * Group 2: Participants with moderate liver impairment * Group 3: Participants with severe liver impairment (only enrolled if Group 2 results are safe and acceptable) Blood samples will be taken to assess how the drug binds to proteins in the blood. Participants will undergo various safety checks and procedures. Participants will stay in the clinical unit until Day 5 for these assessments and will return on Day 10 for a final visit.
Interventions
- DRUG Palovarotene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2025-03-14 |
| Est. Completion | 2026-02-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06908954
The ClinicalTrials.gov registry entry for NCT06908954 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Palovarotene is the first listed.
NCT06908954 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06908954 about?
NCT06908954 is a clinical study titled "A Study of the Blood Levels of Palovarotene in Participants With Abnormal Liver Function Compared to Healthy Adult Participants After Intake of a Single Dose". The main aim of this study is to understand how moderate and severe liver impairment (based on the Child-Pugh classification) affects the body's processing of a single dose of 10 mg maximum of palovarotene, compared to healthy participants with normal liver function. The study will also assess the ...
What is the current status of trial NCT06908954?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2025-03-14. Estimated completion is 2026-02-06.
What interventions are being tested in trial NCT06908954?
The interventions under investigation include: Palovarotene (DRUG).
Who is sponsoring clinical trial NCT06908954?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
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