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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 is a Phase 1 study that has completed, run by Servier Bio-Innovation. The registered enrollment target is 64 participants.
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)
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05843708
The ClinicalTrials.gov registry entry for NCT05843708 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Servier Bio-Innovation, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Vorasidenib 40 mg Oral Tablet is the first listed.
NCT05843708 reports 0 study locations.
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.
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