Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kowa Research Institute, Inc.
• Treatments: Darunavir; Pitavastatin; Ritonavir

Criteria

Inclusion Criteria:

• Healthy adult male or female volunteer aged 18 to 45 years, inclusive.

• Subject has a body mass index of 18 to 30 kg/m2, inclusive.

• Subject has normal hematology, serum chemistry, and urinalysis test results

• Subject is able and willing to abstain from alcohol, grapefruit, caffeine or caffeine containing products, St John's wort, and herbal supplements for 4 days before Day 1 and until completion of the study

• Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug and until study completion.

Exclusion Criteria:

• Subject has had any surgery of the gastrointestinal tract likely to affect drug absorption, distribution, metabolism, or excretion.

• Subject has had a previous allergy or intolerance to treatment with pitavastatin, darunavir, ritonavir, sulfonamides, or any drugs in these classes.

• Subject has a history of drug or alcohol abuse.

• Subject has had a clinically significant illness within 4 weeks before the first dose of study drug.