Drug-Drug Interaction of Lopinavir/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, 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 prior to admission into the clinical unit. Subjects will check into the clinical unit on Day -1 for baseline assessments. There will be one treatment period, with each subject receiving a once daily dose of pitavastatin 4 mg on Days 1 through 5 and Days 20 through 24 and a twice daily dose of lopinavir/ritonavir 400 mg/100 mg (two 200 mg/50 mg tablets per dose) on Days 9 through 24. Pitavastatin will be administered under fasting conditions in the morning and lopinavir/ritonavir will be administered under fasting conditions in the morning and evening.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Pitavastatin (NK-104)
* Drug: Lopinavir/ritonavir


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 for 4 days before Day 1 until after completion of this study. Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug. 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 or lopinavir/ritonavir. 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin<br>Healthy adult subjects | Drug: Pitavastatin (NK-104)<br>* pitavastatin (NK-104) 4 mg once daily (QD)<br>* Other names: Livalo;Drug: Lopinavir/ritonavir<br>* lopinavir/ritonavir 800 mg/200 mg<br>* Other names: Kaletra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time 0 to Tau (AUC 0-τ) | Area under the curve from start to elimination. | 0, 1, 2, 3, 4, 5, 6, 8, and 12 hours after dosing on days 19 and 24 | 

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