Estimation Of Effect Of Ketoconazole On Pharmacokinetics Of Crizotinib In Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions
Healthy
Interventions
DRUG

crizotinib

Treatment A: a single 150-mg dose of crizotinib will be administered in the fasted state on Day 1 as 1 × 50-mg and 1 × 100-mg Immediate Release Tablets.

DRUG

ketoconazole

Treatment B: 200 mg twice a day (approximately 12 hrs apart) doses of ketoconazole will be administered orally on an empty stomach from Day 1 to Day 16.

DRUG

crizotinib

Treatment B: A single 150-mg dose of crizotinib will be administered in the fasted state on Day 4 as 1 × 50-mg and 1 × 100-mg Immediate Release Tablets.

Trial Locations (1)

33143

Pfizer Investigational Site, South Miami

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY