Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

April 1, 2019

Primary Completion Date

May 8, 2019

Study Completion Date

May 22, 2019

Conditions
Healthy Volunteers
Interventions
DRUG

Treatment A - 400 mg Fasting

Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions

DRUG

Treatment B - 400 mg Fed

Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning within 30 minutes (min) after a low-fat standard breakfast meal

DRUG

Treatment C - 200 mg Fed

Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal

Trial Locations (1)

78217

Worldwide Clinical Trials, San Antonio

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Daiichi Sankyo

INDUSTRY