NCT01422369

Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin

Drug-Drug Interaction Study to Assess the Effects of Steady-State Darunavir/Ritonavir on Steady-State Pitavastatin in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pitavastatin (NK-104)	Pitavastatin (NK-104) 4mg once daily (QD)
DRUG	Darunavir/Ritonavir (Prezista)	Darunavir/Ritonavir (Prezista) 800 mg/100 mg

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-08-24
• Last updated: 2012-07-13
• Results posted: 2012-03-15

Locations

1 site across 1 country: United States