Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin

Phase 4

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Pitavastatin (NK-104); Drug: Lopinavir/ritonavir

• Registration Number: NCT01057433
• Lead Sponsor: Kowa Research Institute, Inc.

Brief Summary

This is a Phase 4, single center, open label, fixed-sequence, 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 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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-27
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2012-03-23
• Results First Submitted QC: 2012-07-05
• Results First Posted: 2012-08-13
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pitavastatin	Lopinavir/ritonavir	Healthy adult subjects
Pitavastatin	Pitavastatin (NK-104)	Healthy adult subjects

Primary Outcome Measures

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