Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin

Kowa

Status and phase

Completed

Phase 4

Conditions

Healthy

Treatments

Drug: Pitavastatin (NK-104)

Drug: Darunavir/Ritonavir (Prezista)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01422369

NK-104-4.06US

Details and patient eligibility

About

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

Full 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.

Enrollment

28 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.