A Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz

NCT01472380 | Completed Phase 1 Results

• 1 other identifier: MPC-028-11-1001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 on the pharmacokinetics of single-dose efavirenz in healthy adult subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics: Maximum Plasma Concentration (Cmax)

  The maximum or peak concentration that the drug reaches in the plasma for efavirenz

  serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration

• Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 to Time t[AUC(0-t)]

  The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for efavirenz

  serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration

• Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-infinity]

  The area under the plasma concentration versus time curve from time 0 to infinity. \[AUC(0 to infinity)\] was calculated as the sum of AUC (0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for efavirenz.

  serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration

Study Arms (2)

Efavirenz 600mg alone

ACTIVE COMPARATOR

efavirenz 600mg by mouth taken on Day 1

Drug: efavirenz

Efavirenz co-administered with fenofibric acid

ACTIVE COMPARATOR

co-administered oral doses of efavirenz 600 mg and fenofibric acid 105 mg taken on Day 31

Drug: efavirenz; Drug: fenofibric acid 105 mg

Interventions

efavirenz DRUG

600 mg

Also known as: SUSTIVA

Efavirenz 600mg alone; Efavirenz co-administered with fenofibric acid

fenofibric acid 105 mg DRUG

fenofibric acid 105 mg

Also known as: FIBRICOR

Efavirenz co-administered with fenofibric acid

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Mutual Pharmaceutical Company, Inc.: lead

Study Sites (1)

INC Research

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Interventions

efavirenz; fenofibric acid; Fenofibrate

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Results Point of Contact

• Title: VP, Clinical Development and Medical Affairs
• Organization: Mutual Pharmaceutical Company, Inc.

clinicaltrials@urlmutual.com

215-697-1743

Study Officials

• Matthew Davis, MD

  Mutual Pharmaceutical Company, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2011
• First Posted: November 16, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: August 1, 2012
• Results First Posted: July 23, 2012

Record last verified: 2012-07

Locations

US (1)