Conditions: Healthy
Keywords: Healthy Volunteers
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 28
Healthy volunteers: yes

Brief summary:
This is a Phase 4, single center, open label, fixed-sequence, multiple dose, 2-way drug-drug interaction study.

Detailed description:
This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.

Each subject will qualify for entry into the study not more than 30 days before admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. There will be 1 treatment period, with each subject receiving a once daily dose of pitavastatin 4 mg on Days 1 through 5 and Days 12 through 16 and a once daily dose of darunavir/ritonavir 800 mg/100 mg on Days 6 through 16. On Days 1 through 4, 6 through 10, and 12 through 15, study drug will be administered 30 minutes before a standard breakfast. On Days 5, 11, and 16, subjects will fast at least 8 hours before receiving study drug and remain fasted for 4 hours after dosing.

Arms:
arm 1: pitavastatin 4 mg

Interventions: intervention 1: Pitavastatin (NK-104) intervention 2: Darunavir/Ritonavir (Prezista)
Intervention descriptions: intervention 1: Pitavastatin (NK-104) 4mg once daily (QD) intervention 2: Darunavir/Ritonavir (Prezista) 800 mg/100 mg

Protocol document: