Conditions: Healthy
Keywords: Itraconazole Healthy Volunteers Drug-drug interaction PF-04958242
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 13
Healthy volunteers: yes

Brief summary:
The purpose of the current study is to characterize the pharmacokinetic (PK) profile of PF 04958242 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor.

Detailed description:
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Arms:
arm 1: PF-04958242 will be provided in a capsule. Participants will receive a 0.10 mg loading dose of PF-04958242 twice daily (BID) on Day 1 then 0.025 mg BID on Day 2-Day 16, with the last dose occurring in the morning on Day 17.

Itraconazole will be provided as a solution starting on Day 4. On Day 4, a 200 mg dose of itraconazole will be administered approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4-Day 17).

Interventions: intervention 1: PF-04958242 intervention 2: Itraconazole
Intervention descriptions: intervention 1: Administered as specified in the treatment arm intervention 2: Administered as specified in the treatment arm

Protocol document: