Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin

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

Detailed Description
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Pitavastatin (NK-104)
* Drug: Darunavir/Ritonavir (Prezista)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Subjects<br>pitavastatin 4 mg | Drug: Pitavastatin (NK-104)<br>* Pitavastatin (NK-104) 4mg once daily (QD)<br>Drug: Darunavir/Ritonavir (Prezista)<br>* Darunavir/Ritonavir (Prezista) 800 mg/100 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NK-104 AUC |  | 16 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With at Least One Adverse Event. |  | 16 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers