Four Arm Food Effect Study of Fenofibric Acid Tablets

Mutual Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Fenofibric Acid 105 mg Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960856

MPC-028-07-1009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Fenofibric Acid 105 mg - Low-Fat Meal

Experimental group

Description:

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

Treatment:

Drug: Fenofibric Acid 105 mg Tablet

Drug: Fenofibric Acid 105 mg Tablet

Drug: Fenofibric Acid 105 mg Tablet

Drug: Fenofibric Acid 105 mg Tablet

Fenofibric Acid 105 mg - Standard Meal

Experimental group

Description:

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

Treatment:

Drug: Fenofibric Acid 105 mg Tablet

Drug: Fenofibric Acid 105 mg Tablet

Drug: Fenofibric Acid 105 mg Tablet

Drug: Fenofibric Acid 105 mg Tablet

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

Experimental group

Description:

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

Treatment:

Drug: Fenofibric Acid 105 mg Tablet

Drug: Fenofibric Acid 105 mg Tablet

Drug: Fenofibric Acid 105 mg Tablet

Drug: Fenofibric Acid 105 mg Tablet

Fenofibric Acid 105 mg - Fasted State

Experimental group

Description:

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

Treatment:

Drug: Fenofibric Acid 105 mg Tablet

Drug: Fenofibric Acid 105 mg Tablet

Drug: Fenofibric Acid 105 mg Tablet

Drug: Fenofibric Acid 105 mg Tablet