Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin

Completed · Phase 4

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT01422369

Run by

Kowa Research Institute, Inc.

People needed

28

Starts

2011-04-01

Expected to finish

2011-06-01

Last updated by the study team

2012-07-13

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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