At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
efavirenz +1 moredrug
Likely dose
fenofibric acid 105 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Drug Interaction Study to Investigate the Effects of Steady-State Fenofibric Acid on the Single-Dose Pharmacokinetics of Efavirenz in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating efavirenz and fenofibric acid 105 mg for Healthy. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Efavirenz is predominantly metabolized by cytochrome P450 (CYP) 2B6. Fenofibric Acid is an inhibitor of CYP2B6. This study will evaluate the effect of multiple doses of fenofibric acid at steady-state on the pharmacokinetics of single-dose efavirenz in healthy adult subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedNov 2011
Primary CompletionDec 2011
Study CompletionJan 2012
TodayJul 2026
First PostedNov 16, 2011
Enrollment StartNov 1, 2011
Primary CompletionDec 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.6 years ago
Interventions
efavirenzdrug
600 mg
fenofibric acid 105 mgdrug
fenofibric acid 105 mg