Status:
COMPLETED
A Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01472380
Start Date
November 1 2011
End Date
January 1 2012
Last Update
August 1 2012
Active Locations (1)
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1
INC Research
Morgantown, West Virginia, United States, 26505