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Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin

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ClinicalTrials.gov Identifier: NCT01057433
Recruitment Status : Completed
First Posted : January 27, 2010
Results First Posted : August 13, 2012
Last Update Posted : August 13, 2012
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Pitavastatin (NK-104) Drug: Lopinavir/ritonavir Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Drug-Drug Interaction Study to Assess the Effects of Steady-State Lopinavir/Ritonavir on Pitavastatin in Healthy Adult Volunteers
Study Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pitavastatin
Healthy adult subjects
 Drug: Pitavastatin (NK-104)
pitavastatin (NK-104) 4 mg once daily (QD)
Other Name: Livalo

Drug: Lopinavir/ritonavir
lopinavir/ritonavir 800 mg/200 mg
Other Name: Kaletra


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Curve From Time 0 to Tau (AUC 0-τ) [ Time Frame: 12 hours ]
    Area under the curve from start to elimination.


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 24 Days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057433


Locations
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United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Kowa Research Institute, Inc.
Investigators
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Study Director: Roger Morgan, MD, FACS Kowa Research Institute, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01057433     History of Changes
Other Study ID Numbers: NK-104-4.02US
First Posted: January 27, 2010    Key Record Dates
Results First Posted: August 13, 2012
Last Update Posted: August 13, 2012
Last Verified: July 2012

Keywords provided by Kowa Research Institute, Inc.:
Healthy Volunteers

Additional relevant MeSH terms:
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Ritonavir
Lopinavir
Pitavastatin
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
 Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents