Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin

• 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: Kowa Research Institute, Inc.
• Information provided by (Responsible Party): Kowa Research Institute, Inc.

Tracking Information

• First Submitted Date: January 25, 2010
• First Posted Date: January 27, 2010
• Results First Submitted Date: March 23, 2012
• Results First Posted Date: August 13, 2012
• Last Update Posted Date: August 13, 2012
• Study Start Date: January 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (submitted: January 25, 2010): Adverse Events [ Time Frame: 24 Days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label)
• Condition: Healthy Volunteers

Intervention

• 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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 25, 2010): 24
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01057433
• Other Study ID Numbers: NK-104-4.02US
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kowa Research Institute, Inc.
• Study Sponsor: Kowa Research Institute, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Roger Morgan, MD, FACS; Kowa Research Institute, Inc.

• PRS Account: Kowa Research Institute, Inc.
• Verification Date: July 2012