Conditions: Healthy
Keywords: healthy volunteers crizotinib absolute bioavailability pharmacokinetics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 14
Healthy volunteers: yes

Brief summary:
This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over single-dose study to test the absolute bioavailability of oral crizotinib formulation to IV formulation in healthy adult volunteers. Fourteen (14) subjects will be enrolled to obtain at least 12 evaluable subjects who complete the study. Each subject will receive two treatments (A and B) with a washout period of at least 14 days between each treatment.

Detailed description:
evaluate the absolute bioavailability of oral crizotinib to IV crizotinib.

Arms:
arm 1: Each subject will receive single oral and IV doses of crizotinib separated by at least 14 days.

Interventions: intervention 1: crizotinib intervention 2: crizotinib
Intervention descriptions: intervention 1: Treatment A: Intravenous dose of 50 mg crizotinib will be administered as directed. intervention 2: Treatment B: Oral dose of 250 mg crizotinib as 1 × 50-mg Immediate Release Tablet and 2 × 100-mg Immediate Release Tablets will be administered in the fasted state as directed.

Protocol document: