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NCT05843708 · ClinicalTrials.gov registry record · Phase 1
A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmacokinetics of Vorasidenib in Healthy Subjects
A Phase 1 study, sponsored by Servier Bio-Innovation.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT05843708: Completed Phase 1 study, sponsored by Servier Bio-Innovation.
NCT05843708 is a Phase 1 study that has completed, run by Servier Bio-Innovation. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05843708, a Phase 1 study, has completed, sponsored by Servier Bio-Innovation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
The objectives of this study are: * To evaluate the effect of a low-fat meal on the pharmacokinetics (PK) of vorasidenib following a single oral dose of 40 mg vorasidenib in healthy adult subjects (substudy A) * To evaluate the effect of multiple-dose ciprofloxacin (strong cytochrome P450 \[CYP\]1A2 inhibitor) on the single-dose PK of vorasidenib in healthy adult subjects (substudy B)
Primary Outcome
Maximum observed plasma concentration of vorasidenib in substudy A
Interventions
- DRUG Vorasidenib 40 mg Oral Tablet
- DRUG Ciprofloxacin 500 mg Oral Tablet
- DRUG Vorasidenib 10 mg Oral Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2023-04-14 |
| Est. Completion | 2023-07-28 |
| Phase | Phase 1 |
What the finished NCT05843708 record still lists
NCT05843708 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Vorasidenib 40 mg Oral Tablet is the first listed.
NCT05843708 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05843708 about?
NCT05843708 is a clinical study titled "A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmacokinetics of Vorasidenib in Healthy Subjects". The objectives of this study are: * To evaluate the effect of a low-fat meal on the pharmacokinetics (PK) of vorasidenib following a single oral dose of 40 mg vorasidenib in healthy adult subjects (substudy A) * To evaluate the effect of multiple-dose ciprofloxacin (strong cytochrome P450 \[CYP\]1A...
What is the current status of trial NCT05843708?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2023-04-14. Estimated completion is 2023-07-28.
What interventions are being tested in trial NCT05843708?
The interventions under investigation include: Vorasidenib 40 mg Oral Tablet (DRUG), Ciprofloxacin 500 mg Oral Tablet (DRUG), Vorasidenib 10 mg Oral Tablet (DRUG).
Who is sponsoring clinical trial NCT05843708?
This trial is sponsored by Servier Bio-Innovation, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05843708's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 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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