Conditions: Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 22
Healthy volunteers: yes

Brief summary:
The primary objective of the study is to estimate the effects of different strong enzyme (CYP3A4) inhibitors, itraconazole, diltiazem, or verapamil on the single dose pharmacokinetics of PF-00489791 in healthy volunteers. The study will enroll approximately 18 subjects that are randomized to 1 of 3 treatment groups. The study is also intended to determine the safety and tolerability of single-dose PF- 00489791 when it is administered with steady-state itraconazole, diltiazem, or verapamil.

Detailed description:

Arms:
arm 1: Treatment B subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of itraconazole (200 mg once daily). arm 2: Treatment C subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of diltiazem (240 mg once daily). arm 3: Treatment D subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of verapamil (240 mg once daily).

Interventions: intervention 1: itraconazole intervention 2: diltiazem intervention 3: SR verapamil intervention 4: PF-00489791
Intervention descriptions: intervention 1: itraconazole dosed at 200 mg intervention 2: diltiazem dosed at 240 mg intervention 3: SR verapamil dosed at 240 mg intervention 4: PF-00489791 20 mg single dose administration

Protocol document: