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
1 other identifier
interventional
28
1 country
1
Brief Summary
This is a Phase 4, single center, open label, fixed-sequence, multiple dose, 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
Started Apr 2011
Shorter than P25 for phase_4 healthy
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
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 22, 2011
CompletedFirst Posted
Study publicly available on registry
August 24, 2011
CompletedResults Posted
Study results publicly available
March 15, 2012
CompletedJuly 13, 2012
July 1, 2012
2 months
August 22, 2011
January 3, 2012
July 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NK-104 AUC
16 Days
Secondary Outcomes (1)
Number of Participants With at Least One Adverse Event.
16 Days
Study Arms (1)
All Subjects
EXPERIMENTALpitavastatin 4 mg
Interventions
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, 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.
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, 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Austin, Texas, United States
Related Publications (1)
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.
PMID: 24825411DERIVED
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
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2011
First Posted
August 24, 2011
Study Start
April 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
July 13, 2012
Results First Posted
March 15, 2012
Record last verified: 2012-07