Phase 1 N=30 Basic Science

A Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01472380 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2012

Primary outcome: Primary: Pharmacokinetics: Maximum Plasma Concentration (Cmax) — 2.62; 2.63 ug/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: efavirenz (Drug); fenofibric acid 105 mg (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Mutual Pharmaceutical Company, Inc.
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetics: Maximum Plasma Concentration (Cmax)	2.62; 2.63	—
PRIMARY Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 to Time t[AUC(0-t)]	70.58; 64.62	—
PRIMARY Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-infinity]	121; 112	—

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01472380). 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.