Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Pitavastatin (NK-104); Drug: Darunavir/Ritonavir (Prezista)

• Registration Number: NCT01422369
• Lead Sponsor: Kowa Research Institute, Inc.

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2011-08-22
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-24
• Results First Submitted: 2012-01-03
• Results First Submitted QC: 2012-02-13
• Results First Posted: 2012-03-15
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-05
• Last Update Posted: 2012-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Subjects	Pitavastatin (NK-104)	pitavastatin 4 mg
All Subjects	Darunavir/Ritonavir (Prezista)	pitavastatin 4 mg

Primary Outcome Measures

Name	Time	Method
NK-104 AUC	16 Days

Secondary Outcome Measures

Name	Time	Method
Number of Participants With at Least One Adverse Event.	16 Days