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

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

April 14, 2023

Primary Completion Date

July 28, 2023

Study Completion Date

July 28, 2023

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)

Trial Locations (1)

78744

PPD Development, Austin

All Listed Sponsors
collaborator

Institut de Recherches Internationales Servier

OTHER

lead

Servier Bio-Innovation LLC

INDUSTRY