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

Part of paid clinical trials in Austin, Texas.

Sponsor
Servier Bio-Innovation LLC
Study ID
NCT05843708
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Vorasidenib 40 mg Oral Tablet — DRUG
    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)
  • Ciprofloxacin 500 mg Oral Tablet — DRUG
    Twice daily (morning and evening) oral doses of ciprofloxacin 1×500 mg tablet on Days 1 through 14 (Substudy B)
  • Vorasidenib 10 mg Oral Tablet — DRUG
    Single oral dose of vorasidenib 2×10 mg tablets administered on Day 1 (Substudy B)

Study Details

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)

Key Dates

Start date
Apr 14, 2023
Status verified
Feb 2025
Primary completion
Jul 28, 2023
Completion
Jul 28, 2023

Study Design

Enrollment
64 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Fasting condition / Low-fat meal
    A single oral dose of 1×40 mg vorasidenib tablet administered under fasted conditions or following a low-fat meal.
  • Experimental: Low-fat meal / Fasted condition
    A single oral dose of 1×40 mg vorasidenib tablet administered following a low-fat meal or under fasted conditions.
  • Experimental: Vorasidenib
    Single oral dose of vorasidenib 2×10 mg tablets administered on Day 1.
  • Experimental: Vorasidenib and ciprofloxacin
    Single oral dose of vorasidenib 2×10 mg tablets administered on Day 1 and twice daily (morning and evening) oral doses of ciprofloxacin 1×500 mg tablet on Days 1 through 14.

Primary Outcome Measure

Cmax of Vorasidenib (substudy A) [ Time Frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
PPD DevelopmentAustinTexas78744-

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By research site
PPD Development· Austin, TX

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