Conditions: Healthy
Keywords: crizotinib healthy volunteers ketoconazole pharmacokinetics single dose
Allocation: NON_RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 15
Healthy volunteers: yes

Brief summary:
The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the single dose pharmacokinetics of crizotinib in healthy volunteers.

Detailed description:

Arms:
arm 1: There should be at least 14-day washout period between treatment A and B.

Interventions: intervention 1: crizotinib intervention 2: ketoconazole intervention 3: crizotinib
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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.

Protocol document: