CompletedNCT00960856Updated Oct 20, 2009Results posted

Four Arm Food Effect Study of Fenofibric Acid Tablets

A Phase 1 interventional study of Fenofibric Acid 105 mg Tablet and Fenofibric Acid 105 mg Tablet in Healthy, sponsored by Mutual Pharmaceutical Company, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-10-20.

Sponsored by Mutual Pharmaceutical Company, Inc. · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study 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.

Read the 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 studied

Healthy

Keywords

pharmacokinetics

In context

Lead sponsor

Mutual Pharmaceutical Company, Inc. is the lead sponsor of 44 studies on the registry; none are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 40 participants (actual)

Study arms

Experimental
Fenofibric Acid 105 mg - Low-Fat Meal
Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.
Drug: Fenofibric Acid 105 mg Tablet
Experimental
Fenofibric Acid 105 mg - Standard Meal
Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a standard breakfast.
Drug: Fenofibric Acid 105 mg Tablet
Experimental
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.
Drug: Fenofibric Acid 105 mg Tablet
Experimental
Fenofibric Acid 105 mg - Fasted State
Fenofibric Acid 105 mg tablet administered after an overnight fast of at least 10 hours
Drug: Fenofibric Acid 105 mg Tablet

Interventions

DrugFenofibric Acid 105 mg Tablet
One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.
DrugFenofibric Acid 105 mg Tablet
One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast
DrugFenofibric Acid 105 mg Tablet
One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.
DrugFenofibric Acid 105 mg Tablet
One 105 mg tablet administered after an overnight fast of at least 10 hours.

What researchers measure

Primary outcomes

Maximum Plasma Concentration (Cmax)
The maximum or peak concentration that the drug reaches in the plasma.
Time frame: serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration
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.
Time frame: serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
The area under the plasma concentration versus time curve from time 0 to infinity. AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Time frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.

Results

Posted Oct 14, 2009

Participant flow

Non-obese, non-smoking, healthy adult volunteers consisting of members of the community-at-large were enrolled.

Period I

Participant flow — Period I
Milestone	Sequence ABCD	Sequence BCDA	Sequence CDAB	Sequence DABC
Started	10	9	9	9
Completed	10	9	9	9
Not completed	0	0	0	0

Washout Period of 7 Days

Participant flow — Washout Period of 7 Days
Milestone	Sequence ABCD	Sequence BCDA	Sequence CDAB	Sequence DABC
Started	10	9	9	9
Completed	10	7	9	9
Not completed	0	2	0	0
Withdrew: Withdrawal by subject	0	2	0	0

Period II

Participant flow — Period II
Milestone	Sequence ABCD	Sequence BCDA	Sequence CDAB	Sequence DABC
Started	10	7	9	9
Completed	10	7	9	9
Not completed	0	0	0	0

Washout Period of 7 Days

Participant flow — Washout Period of 7 Days
Milestone	Sequence ABCD	Sequence BCDA	Sequence CDAB	Sequence DABC
Started	10	7	9	9
Completed	10	7	9	9
Not completed	0	0	0	0

Period III

Participant flow — Period III
Milestone	Sequence ABCD	Sequence BCDA	Sequence CDAB	Sequence DABC
Started	10	7	9	9
Completed	10	7	9	9
Not completed	0	0	0	0

Washout Period of 7 Days

Participant flow — Washout Period of 7 Days
Milestone	Sequence ABCD	Sequence BCDA	Sequence CDAB	Sequence DABC
Started	10	7	9	9
Completed	10	7	8	9
Not completed	0	0	1	0
Withdrew: Adverse event	0	0	1	0

Period IV

Participant flow — Period IV
Milestone	Sequence ABCD	Sequence BCDA	Sequence CDAB	Sequence DABC
Started	10	7	8	9
Completed	10	7	8	9
Not completed	0	0	0	0

Outcome measures

PrimaryMaximum Plasma Concentration (Cmax)

The maximum or peak concentration that the drug reaches in the plasma.

Time frame:: serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration
Reported as:: Mean · ng/mL

Maximum Plasma Concentration (Cmax)
ng/mL	Low-fat Meal - Treatment A	Standard Meal - Treatment B	High-Fat, High-Calorie Meal - Treatment C	Fasted - Treatment D
Maximum Plasma Concentration (Cmax)	9,806.74 ± 2,120.78	9,854.39 ± 1,980.77	7,950.75 ± 1,920.85	12,061.67 ± 2,241.31

PrimaryArea 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.

Time frame:: serial pharmacokinetic blood samples drawn immediately prior to dosing and then 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours after dose administration
Reported as:: Mean · ng-hr/mL

Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
ng-hr/mL	Low-fat Meal - Treatment A	Standard Meal - Treatment B	High-Fat, High-Calorie Meal - Treatment C	Fasted - Treatment D
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]	132,636.84 ± 47,627.60	134,928.11 ± 50,262.64	134,814.42 ± 47,130.53	139,975.28 ± 48,821.99

PrimaryThe Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)

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

Time frame:: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration.
Reported as:: Mean · ng-hr/mL

The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
ng-hr/mL	Low-fat Meal - Treatment A	Standard Meal - Treatment B	High-Fat, High-Calorie Meal - Treatment C	Fasted - Treatment D
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)	145,827.10 ± 56,137.08	148,367.21 ± 58,828.43	148,488.53 ± 55,949.04	152,571.61 ± 55,060.83

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Low-Fat Meal - Treatment A	—	0/35 (0%)	9/35 (25.7%)
Standard Meal - Treatment B	—	0/36 (0%)	2/36 (5.6%)
High-fat, High-calorie Meal - Treatment C	—	0/35 (0%)	4/35 (11.4%)
Fasted - Treatment D	—	0/35 (0%)	4/35 (11.4%)

Most frequent other events

Most frequent other events
Event	Low-Fat Meal - Treatment A	Standard Meal - Treatment B	High-fat, High-calorie Meal - Treatment C	Fasted - Treatment D
HeadacheNervous system disorders	3/35	0/36	3/35	0/35
NauseaGastrointestinal disorders	0/35	0/36	0/35	2/35
DiarrheaGastrointestinal disorders	1/35	0/36	0/35	0/35
VomitingGastrointestinal disorders	1/35	0/36	0/35	0/35
Vessel puncture site hematomaGeneral disorders	1/35	1/36	0/35	1/35
Vessel puncture site painGeneral disorders	1/35	0/36	0/35	0/35
Vessel puncture site reactionGeneral disorders	1/35	0/36	0/35	0/35
Blood creatine kinase increasedInvestigations	0/35	1/36	1/35	0/35
DizzinessNervous system disorders	1/35	0/36	0/35	1/35

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Low-Fat Meal, Standard Meal, High Fat/High Calorie Meal,Fasted
<=18 years	0
Between 18 and 65 years	37
>=65 years	0

Age Continuous
Age Continuous(years)	Low-Fat Meal, Standard Meal, High Fat/High Calorie Meal,Fasted
Mean	23.89 ± 6.27

Sex: Female, Male
Sex: Female, Male(Participants)	Low-Fat Meal, Standard Meal, High Fat/High Calorie Meal,Fasted
Female	21
Male	16

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Low-Fat Meal, Standard Meal, High Fat/High Calorie Meal,Fasted
Hispanic or Latino	2
Not Hispanic or Latino	35
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Low-Fat Meal, Standard Meal, High Fat/High Calorie Meal,Fasted
American Indian or Alaska Native	1
Asian	2
Native Hawaiian or Other Pacific Islander	0
Black or African American	1
White	33
More than one race	0
Unknown or Not Reported	0

Study locations

1 site

PRACS Institute, Ltd. - Cetero Research
Fargo, North Dakota 58104, United States

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2007, a primary completion of Nov 2007 and a completion of Nov 2007. It does not say whether these dates are actual or estimated.

Results were first posted in Oct 2009, 1 year 11 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 14, 2009
First posted: Aug 18, 2009
Start: Nov 2007
Primary completionActual: Nov 2007
CompletionActual: Nov 2007
Results first posted: Oct 14, 2009
Last update: Oct 20, 2009

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 20, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00960856
Lead sponsor: Mutual Pharmaceutical Company, Inc.
First posted: Aug 18, 2009
Start date: Nov 2007
Primary completion: Nov 2007
Completion: Nov 2007
Results posted: Oct 14, 2009
Last update: Oct 20, 2009

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Fenofibric acid

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Four Arm Food Effect Study of Fenofibric Acid Tablets

Study summary

Conditions studied

Keywords

In context

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

Timeline

Registry details

Key details

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies from this sponsor

Inclusion criteria

Exclusion criteria