Phase 1 Completed N=30 Randomized Basic Science

Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz

Healthy

Source: ClinicalTrials.gov NCT00960570 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2009

Primary outcomePrimary: Maximum Plasma Concentration (Cmax) of Efavirenz — 2,461.58; 2,384.79 ng/mL

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Plasma Concentration (Cmax) of Efavirenz	2,461.58; 2,384.79	—
PRIMARY Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]	70,144.35; 63,313.23	—
PRIMARY Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]	106,689.60; 96,382.08	—

Eligibility Criteria

Inclusion Criteria

Healthy adults 18-45 years of age
Non-smoking
Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures)
Body mass index (BMI) less than 30
Medically healthy on the basis of medical history and physical examination
Hemoglobin > or = to 12g/dL
Completion of the screening process within 28 days prior to dosing
Provision of voluntary written informed consent

Exclusion Criteria

Recent participation (within 28 days) 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, or psychiatric 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 to fenofibric acid or efavirenz

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00960570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.