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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

NCT05843708 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-02-14

No results posted yet for this 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)

Conditions

  • Healthy Subjects

Interventions

DRUG

Vorasidenib 40 mg Oral Tablet

Single oral dose of 1×40 mg vorasidenib tablet administered : * under fasted conditions (all subjects will fast overnight for at least 10 hours prior to dosing and for at least 4 hours after dosing. * or following a low fat meal (approximatively 400 to 500 calories) (Substudy A)

DRUG

Ciprofloxacin 500 mg Oral Tablet

Twice daily (morning and evening) oral doses of ciprofloxacin 1×500 mg tablet on Days 1 through 14 (Substudy B)

DRUG

Vorasidenib 10 mg Oral Tablet

Single oral dose of vorasidenib 2×10 mg tablets administered on Day 1 (Substudy B)

Sponsors & Collaborators

  • Institut de Recherches Internationales Servier

    collaborator OTHER

  • Servier Bio-Innovation LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-14
Primary Completion
2023-07-28
Completion
2023-07-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05843708 on ClinicalTrials.gov