Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin
Drug-Drug Interaction Study to Assess the Effects of Steady-State Lopinavir/Ritonavir on Pitavastatin in Healthy Adult Volunteers
1 other identifier
interventional
24
1 country
1
Brief Summary
This is a Phase 4, single center, open label, fixed-sequence, 2-way drug-drug interaction study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 healthy-volunteers
Started Jan 2010
Typical duration for phase_4 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 25, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
August 13, 2012
CompletedJune 22, 2021
June 1, 2021
11 months
January 25, 2010
March 23, 2012
June 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under the Curve From Time 0 to Tau (AUC 0-τ)
Area under the curve from start to elimination.
0, 1, 2, 3, 4, 5, 6, 8, and 12 hours after dosing on days 19 and 24
Study Arms (1)
Pitavastatin
EXPERIMENTALHealthy adult subjects
Interventions
pitavastatin (NK-104) 4 mg once daily (QD)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Austin, Texas, United States
Related Publications (1)
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.
PMID: 22627182DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roger Morgan, MD, FACS
- Organization
- Kowa Research Institute, Inc.
Study Officials
- STUDY DIRECTOR
Roger Morgan, MD, FACS
Kowa Research Institute, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2010
First Posted
January 27, 2010
Study Start
January 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
June 22, 2021
Results First Posted
August 13, 2012
Record last verified: 2021-06