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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.

Tracking Information
First Submitted Date  ICMJE January 25, 2010
First Posted Date  ICMJE January 27, 2010
Results First Submitted Date  ICMJE March 23, 2012
Results First Posted Date  ICMJE August 13, 2012
Last Update Posted Date August 13, 2012
Study Start Date  ICMJE January 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2012)
Area Under the Curve From Time 0 to Tau (AUC 0-τ) [ Time Frame: 12 hours ]
Area under the curve from start to elimination.
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2010)
NK-104 plasma levels [ Time Frame: 24 Days ]
Change History Complete list of historical versions of study NCT01057433 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2010)
Adverse Events [ Time Frame: 24 Days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin
Official Title  ICMJE Drug-Drug Interaction Study to Assess the Effects of Steady-State Lopinavir/Ritonavir on Pitavastatin in Healthy Adult Volunteers
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Pitavastatin
Healthy adult subjects
Interventions:
  • Drug: Pitavastatin (NK-104)
  • Drug: Lopinavir/ritonavir
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2010)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01057433
Other Study ID Numbers  ICMJE NK-104-4.02US
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kowa Research Institute, Inc.
Study Sponsor  ICMJE Kowa Research Institute, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Roger Morgan, MD, FACS Kowa Research Institute, Inc.
PRS Account Kowa Research Institute, Inc.
Verification Date July 2012

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