A Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01472380

Run by

Mutual Pharmaceutical Company, Inc.

People needed

30

Starts

2011-11-01

Expected to finish

2012-01-01

Last updated by the study team

2012-08-01

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures), with a body mass index (BMI) greater or equal to 18 and less than or equal to 32kg/m2, hemoglobin >12 g/dL.

You may not qualify if…

• recent participation (within past month) in other research studies
• Recent significant blood donation or plasma donation
• Pregnant or lactating
• Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
• Recent (2-year) history or evidence of alcoholism or drug abuse
• History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease or active sexually transmitted disease
• Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
• Drug allergies or sensitivities to efavirenz, fenofibrate, fenofibric acid or any component of the two formulations
• Subjects who have had a tattoo or body piercing within 30 days prior to administration of study medication

Where it is running

• INC Research — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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