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Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin

NCT ID: NCT01422369

Last Updated: 2012-07-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-06-30

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.

Conditions

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Healthy

Keywords

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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All Subjects

pitavastatin 4 mg

Group Type EXPERIMENTAL

Pitavastatin (NK-104)

Intervention Type DRUG

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

Darunavir/Ritonavir (Prezista)

Intervention Type DRUG

Darunavir/Ritonavir (Prezista) 800 mg/100 mg

Interventions

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Pitavastatin (NK-104)

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

Intervention Type DRUG

Darunavir/Ritonavir (Prezista)

Darunavir/Ritonavir (Prezista) 800 mg/100 mg

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kowa Research Institute, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roger Morgan, MD, FACS

Role: STUDY_DIRECTOR

Kowa Research Institute, Inc.

Locations

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Austin, Texas, United States

Site Status

Countries

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United States

References

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Yu CY, Campbell SE, Sponseller CA, Small DS, Medlock MM, Morgan RE. Steady-state pharmacokinetics of darunavir/ritonavir and pitavastatin when co-administered to healthy adult volunteers. Clin Drug Investig. 2014 Jul;34(7):475-82. doi: 10.1007/s40261-014-0198-x.

Reference Type DERIVED
PMID: 24825411 (View on PubMed)

Other Identifiers

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NK-104-4.06US

Identifier Type: -

Identifier Source: org_study_id