Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin

NCT ID: NCT01057433

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-12-31

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pitavastatin

Healthy adult subjects

Group Type: EXPERIMENTAL

Pitavastatin (NK-104)

Intervention Type: DRUG

pitavastatin (NK-104) 4 mg once daily (QD)

Lopinavir/ritonavir

Intervention Type: DRUG

lopinavir/ritonavir 800 mg/200 mg

Interventions

Pitavastatin (NK-104)

pitavastatin (NK-104) 4 mg once daily (QD)

Intervention Type: DRUG

Lopinavir/ritonavir

lopinavir/ritonavir 800 mg/200 mg

Intervention Type: DRUG

Other Intervention Names

Livalo; Kaletra

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kowa Research Institute, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger Morgan, MD, FACS

Role: STUDY_DIRECTOR

Kowa Research Institute, Inc.

Locations

Austin, Texas, United States

Countries

United States

References

Morgan RE, Campbell SE, Suehira K, Sponseller CA, Yu CY, Medlock MM. Effects of steady-state lopinavir/ritonavir on the pharmacokinetics of pitavastatin in healthy adult volunteers. J Acquir Immune Defic Syndr. 2012 Jun 1;60(2):158-64. doi: 10.1097/QAI.0b013e318251addb.

Reference Type: DERIVED

PMID: 22627182 (View on PubMed)

Other Identifiers

NK-104-4.02US

Identifier Type: -

Identifier Source: org_study_id