Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Efavirenz is predominantly metabolized by cytochrome P450 (CYP) 2B6. Fenofibric Acid is an
      inhibitor of CYP 2B6. 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.
    

Detailed description: 
      Efavirenz is predominantly metabolized by cytochrome P450 (CYP) 2B6. Fenofibric Acid is an
      inhibitor of CYP 2B6. 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. On study Day 1 after a fast of at least 10 hours, thirty healthy, non-smoking,
      non-obese, non-pregnant adult volunteers between the ages of 18 and 45 will be given one oral
      dose of efavirenz (1 x 600 mg tablet). Fasting will continue for 4 hours after the dose.
      Blood samples will be drawn from all participants before dosing and for 120 hours post-dose
      at times sufficient to adequately define the pharmacokinetics of efavirenz. A 21 day washout
      period will be completed after the first dose of efavirenz on Day 1. On Days 22 through 30,
      all subjects will receive a single oral dose of fenofibric acid (1 x 105 mg tablet) in the
      morning without regard to meals. On the morning of Day 31 after a fast of at least 10 hours,
      all study participants will receive co-administered single oral doses of efavirenz (1 x 600
      mg tablet) and fenofibric acid (1 x 105 mg tablet). Fasting will continue for 4 hours after
      the dose. Blood samples will be drawn from all participants before dosing and for 120 hours
      post-dose at times sufficient to adequately determine the pharmacokinetics of efavirenz. A
      further goal of this study is to evaluate the safety and tolerability of this regimen in
      healthy volunteers. Subjects will be monitored throughout participation in the study for
      adverse reactions to the study drug and/or procedures. Vital signs (seated blood pressure and
      pulse) will be measured prior to dosing and at approximately 1, 2, 3 and 5 hours post-dose on
      Days 1 and 31 and prior to dosing and at approximately 1, 2 and 4 hours post-dose on Day 22
      to coincide with peak plasma concentrations of both efavirenz and fenofibric acid. All
      adverse events whether elicited by query, spontaneously reported, or observed by clinic staff
      will be evaluated by the Investigator and reported in the subject's case report form.
    

Intervention name(s): Efavirenz 600 mg; Efavirenz 600 mg; Fenofibric Acid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Efavirenz 600 mg administered as a single oral dose on the morning of Day 1.; Co-administered single oral doses of Efavirenz 600 mg and Fenofibric Acid 105 mg on Day 31.; Co-administered single oral doses of Efavirenz 600 mg and Fenofibric Acid 105 mg on Day 31.
Intervention MeSH terms: Efavirenz; Fenofibric acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy; adult; efavirenz; fenofibric acid; blood levels