Trial Outcomes & Findings for Four Arm Food Effect Study of Fenofibric Acid Tablets (NCT NCT00960856)
NCT ID: NCT00960856
Last Updated: 2009-10-20
Results Overview
The maximum or peak concentration that the drug reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
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
Results posted on
2009-10-20
Participant Flow
Non-obese, non-smoking, healthy adult volunteers consisting of members of the community-at-large were enrolled.
88 subjects were screened and 51 were screen failures. Enrollment of 40 subjects was planned, however, the enrollment of 37 subjects was judged to be sufficient to meet the criterion of 36 necessary to complete the study.
Participant milestones
| Measure |
Sequence ABCD
Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.
|
Sequence BCDA
Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state
|
Sequence CDAB
Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state
|
Sequence DABC
Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.
|
|---|---|---|---|---|
|
Period I
STARTED
|
10
|
9
|
9
|
9
|
|
Period I
COMPLETED
|
10
|
9
|
9
|
9
|
|
Period I
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period of 7 Days
STARTED
|
10
|
7
|
9
|
9
|
|
Washout Period of 7 Days
COMPLETED
|
10
|
7
|
8
|
9
|
|
Washout Period of 7 Days
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Period II
STARTED
|
10
|
7
|
9
|
9
|
|
Period II
COMPLETED
|
10
|
7
|
9
|
9
|
|
Period II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period III
STARTED
|
10
|
7
|
9
|
9
|
|
Period III
COMPLETED
|
10
|
7
|
9
|
9
|
|
Period III
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Period IV
STARTED
|
10
|
7
|
8
|
9
|
|
Period IV
COMPLETED
|
10
|
7
|
8
|
9
|
|
Period IV
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence ABCD
Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.
|
Sequence BCDA
Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state
|
Sequence CDAB
Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state
|
Sequence DABC
Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.
|
|---|---|---|---|---|
|
Washout Period of 7 Days
Withdrawal by Subject
|
0
|
2
|
0
|
0
|
|
Washout Period of 7 Days
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Four Arm Food Effect Study of Fenofibric Acid Tablets
Baseline characteristics by cohort
| Measure |
Low-Fat Meal, Standard Meal, High Fat/High Calorie Meal,Fasted
n=37 Participants
All subjects received each of the four study regimens in a randomly assigned sequence of dosing periods. On the mornings of Days 1, 8, 15 and 22 each subject received one tablet of fenofibric acid 105 mg administered after one of the following meal conditions: 1) low-fat meal, 2) standard meal, 3) high-fat/high-calorie meal 4) overnight fast of at least 10 hours.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
23.89 years
STANDARD_DEVIATION 6.27 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.
The maximum or peak concentration that the drug reaches in the plasma.
Outcome measures
| Measure |
Low-fat Meal - Treatment A
n=34 Participants
Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
|
Standard Meal - Treatment B
n=34 Participants
Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
|
High-Fat, High-Calorie Meal - Treatment C
n=34 Participants
Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
|
Fasted - Treatment D
n=34 Participants
Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
9,806.74 ng/mL
Standard Deviation 2,120.78
|
9,854.39 ng/mL
Standard Deviation 1,980.77
|
7,950.75 ng/mL
Standard Deviation 1,920.85
|
12,061.67 ng/mL
Standard Deviation 2,241.31
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.
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.
Outcome measures
| Measure |
Low-fat Meal - Treatment A
n=34 Participants
Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
|
Standard Meal - Treatment B
n=34 Participants
Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
|
High-Fat, High-Calorie Meal - Treatment C
n=34 Participants
Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
|
Fasted - Treatment D
n=34 Participants
Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
132,636.84 ng-hr/mL
Standard Deviation 47,627.60
|
134,928.11 ng-hr/mL
Standard Deviation 50,262.64
|
134,814.42 ng-hr/mL
Standard Deviation 47,130.53
|
139,975.28 ng-hr/mL
Standard Deviation 48,821.99
|
PRIMARY outcome
Timeframe: 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.Population: Pharmacokinetic analyses of fenofibric acid are based on 34 subjects who completed the study. One subject discontinued due to an adverse event and two subjects discontinued for personal reasons.
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.
Outcome measures
| Measure |
Low-fat Meal - Treatment A
n=34 Participants
Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
|
Standard Meal - Treatment B
n=34 Participants
Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
|
High-Fat, High-Calorie Meal - Treatment C
n=34 Participants
Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
|
Fasted - Treatment D
n=34 Participants
Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
The Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity AUC(0-∞)
|
145,827.10 ng-hr/mL
Standard Deviation 56,137.08
|
148,367.21 ng-hr/mL
Standard Deviation 58,828.43
|
148,488.53 ng-hr/mL
Standard Deviation 55,949.04
|
152,571.61 ng-hr/mL
Standard Deviation 55,060.83
|
Adverse Events
Low-Fat Meal - Treatment A
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Standard Meal - Treatment B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
High-fat, High-calorie Meal - Treatment C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Fasted - Treatment D
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low-Fat Meal - Treatment A
n=35 participants at risk
Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
|
Standard Meal - Treatment B
n=36 participants at risk
Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
|
High-fat, High-calorie Meal - Treatment C
n=35 participants at risk
Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
|
Fasted - Treatment D
n=35 participants at risk
Each subject received one tablet of 105 mg fenofibric acid following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
1/35 • Number of events 1
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/36
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/35
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/35
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/35
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/36
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/35
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
5.7%
2/35 • Number of events 2
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/35 • Number of events 1
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/36
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/35
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/35
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
|
General disorders
Vessel puncture site hematoma
|
2.9%
1/35 • Number of events 1
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
2.8%
1/36 • Number of events 1
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/35
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
2.9%
1/35 • Number of events 1
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
|
General disorders
Vessel puncture site pain
|
2.9%
1/35 • Number of events 1
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/36
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/35
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/35
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
|
General disorders
Vessel puncture site reaction
|
2.9%
1/35 • Number of events 1
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/36
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/35
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/35
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
|
Investigations
Blood creatine kinase increased
|
0.00%
0/35
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
2.8%
1/36 • Number of events 1
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
2.9%
1/35 • Number of events 1
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/35
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
|
Nervous system disorders
Dizziness
|
2.9%
1/35 • Number of events 1
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/36
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/35
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
2.9%
1/35 • Number of events 1
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
|
Nervous system disorders
Headache
|
8.6%
3/35 • Number of events 3
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/36
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
8.6%
3/35 • Number of events 3
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
0.00%
0/35
37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60