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NCT04223635 · ClinicalTrials.gov registry record · Early Phase 1
Study of Pexidartinib in Participants With Moderate Hepatic Impairment Compared With Healthy Participants
A Early Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
NCT04223635: Completed Early Phase 1 study, sponsored by Daiichi Sankyo.
NCT04223635 is a Early Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 16 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04223635, a Early Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The pharmacokinetics of a single dose of pexidartinib was investigated in participants with impaired hepatic function and compared with healthy control participants with normal hepatic function.
Primary Outcome
Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration and was calculated using non-compartmental analysis.
Interventions
- DRUG Pexidartinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-01-07 |
| Est. Completion | 2020-10-02 |
| Phase | Early Phase 1 |
What the finished NCT04223635 record still lists
NCT04223635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Pexidartinib is the first listed.
NCT04223635 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04223635 about?
NCT04223635 is a clinical study titled "Study of Pexidartinib in Participants With Moderate Hepatic Impairment Compared With Healthy Participants". The pharmacokinetics of a single dose of pexidartinib was investigated in participants with impaired hepatic function and compared with healthy control participants with normal hepatic function.
What is the current status of trial NCT04223635?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2020-01-07. Estimated completion is 2020-10-02.
What interventions are being tested in trial NCT04223635?
The interventions under investigation include: Pexidartinib (DRUG).
Who is sponsoring clinical trial NCT04223635?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04223635's enrollment target sits among peer trials
16 1369th of 2000 higher than 598 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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