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Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01422369
First received: August 22, 2011
Last updated: July 5, 2012
Last verified: July 2012
History of Changes

August 22, 2011
July 5, 2012
April 2011
June 2011   (final data collection date for primary outcome measure)
NK-104 AUC [ Time Frame: 16 Days ] [ Designated as safety issue: No ]
NK-104 plasma levels [ Time Frame: 16 Days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01422369 on ClinicalTrials.gov Archive Site
Number of Participants With at Least One Adverse Event. [ Time Frame: 16 Days ] [ Designated as safety issue: Yes ]
Adverse Events [ Time Frame: 16 Days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin
Drug-Drug Interaction Study to Assess the Effects of Steady-State Darunavir/Ritonavir on Steady-State Pitavastatin in Healthy Adult Volunteers

This is a Phase 4, single center, open label, fixed-sequence, multiple dose, 2-way drug-drug interaction study.

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.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy
  • Drug: Pitavastatin (NK-104)
    Pitavastatin (NK-104) 4mg once daily (QD)
  • Drug: Darunavir/Ritonavir (Prezista)
    Darunavir/Ritonavir (Prezista) 800 mg/100 mg
Experimental: All Subjects
pitavastatin 4 mg
Interventions:
  • Drug: Pitavastatin (NK-104)
  • Drug: Darunavir/Ritonavir (Prezista)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01422369
NK-104-4.06US
No
Kowa Research Institute, Inc.
Kowa Research Institute, Inc.
Not Provided
Study Director: Roger Morgan, MD, FACS Kowa Research Institute, Inc.
Kowa Research Institute, Inc.
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP