Four Arm Food Effect Study of Fenofibric Acid Tablets

NCT ID: NCT00960856

Last Updated: 2009-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2007-11-30

Brief Summary

The primary objective of this study is to characterize the single-dose pharmacokinetic profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat compositions on the rate and extent of absorption. Additionally, the safety and tolerability of this dose and regimen of fenofibric acid will be evaluated.

Detailed Description

The primary objective of this study is to determine the single-dose pharmacokinetic profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat compositions on the rate and extent of absorption. Forty healthy, non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18 and 45 years old will receive a single oral dose of fenofibric acid in one of four randomly assigned sequences of meal conditions each separated by a 7 day washout period. On study Days 1, 8, 15 and 22 each subject will receive a single oral dose (1 x 105 mg tablet) of fenofibric acid following an overnight fast of at least 10 hours or with a low-fat meal, standard meal, or high-fat/high-calorie meal according to their randomization sequence. Subjects will fast for at least 4.25 hours after dosing in each of the four dosing conditions. Blood samples will be drawn from all participants before dosing and for 72 hours post-dose at times sufficient to adequately define the pharmacokinetics of fenofibric acid. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Seated blood pressure and heart rate will be measured prior to dosing and at 2 hours post-dose. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fenofibric Acid 105 mg - Low-Fat Meal

Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.

Group Type: EXPERIMENTAL

Fenofibric Acid 105 mg Tablet

Intervention Type: DRUG

One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.

Fenofibric Acid 105 mg - Standard Meal

Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a standard breakfast.

Group Type: EXPERIMENTAL

Fenofibric Acid 105 mg Tablet

Intervention Type: DRUG

One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast

Fenofibric Acid 105 mg - High-Fat/High-Calorie Meal

Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.

Group Type: EXPERIMENTAL

Fenofibric Acid 105 mg Tablet

Intervention Type: DRUG

One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.

Fenofibric Acid 105 mg - Fasted State

Fenofibric Acid 105 mg tablet administered after an overnight fast of at least 10 hours

Group Type: EXPERIMENTAL

Fenofibric Acid 105 mg Tablet

Intervention Type: DRUG

One 105 mg tablet administered after an overnight fast of at least 10 hours.

Interventions

Fenofibric Acid 105 mg Tablet

One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.

Intervention Type: DRUG

Fenofibric Acid 105 mg Tablet

One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast

Intervention Type: DRUG

Fenofibric Acid 105 mg Tablet

One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.

Intervention Type: DRUG

Fenofibric Acid 105 mg Tablet

One 105 mg tablet administered after an overnight fast of at least 10 hours.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy adults between the ages of 18 and 45
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mutual Pharmaceutical Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Mutual Pharmaceutical Company, Inc.

Locations

PRACS Institute, Ltd. - Cetero Research

Fargo, North Dakota, United States

Countries

United States

Other Identifiers

MPC-028-07-1009

Identifier Type: -

Identifier Source: org_study_id