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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: Completed Phase 1 study, sponsored by Ipsen.
NCT06908954 is a Phase 1 study that has completed, run by Ipsen. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measure of maximum observed plasma drug concentration (Cmax) (total and unbound) over 96 hours after dosing
Interventions
- DRUG Palovarotene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2025-03-14 |
| Est. Completion | 2026-02-06 |
| Phase | Phase 1 |
What the finished NCT06908954 record still lists
NCT06908954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which Palovarotene is the first listed.
NCT06908954 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06908954's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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