ClinicalTrials.gov
ClinicalTrials.gov Menu

Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00960570
Recruitment Status : Completed
First Posted : August 18, 2009
Results First Posted : October 14, 2009
Last Update Posted : August 7, 2012
Sponsor:
Information provided by (Responsible Party):
Mutual Pharmaceutical Company, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: Efavirenz 600 mg
Drug: Fenofibric Acid
Enrollment 30
Recruitment Details Thirty (30) healthy, non-smoking adult male and female volunteers from the community at-large were enrolled.
Pre-assignment Details Forty-nine (49) subjects were screened. Nineteen (19) were screen failures.
Arm/Group Title Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA
Hide Arm/Group Description On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours.
Period Title: Efavirenz Alone
Started 30
Completed 30
Not Completed 0
Period Title: 21 Day Washout Period
Started 30
Completed 28
Not Completed 2
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Period Title: Fenofibric Acid Alone
Started 28
Completed 28
Not Completed 0
Period Title: 1 Day Period Between Dosing
Started 28
Completed 25
Not Completed 3
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             1
Period Title: Efavirenz and Fenofibric Acid
Started 25
Completed 25
Not Completed 0
Arm/Group Title Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA
Hide Arm/Group Description On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
26.8  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
13
  43.3%
Male
17
  56.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  10.0%
White
27
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of Efavirenz
Hide Description The maximum or peak concentration that efavirenz reaches in the plasma.
Time Frame serial pharmacokinetic blood samples drawn 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
30 subjects were enrolled in this study. A total of 6 subjects withdrew. One of those 6 subjects completed all dosing of study interventions but withdrew consent prior to the 8 hour post-dose activities on Day 31.
Arm/Group Title Efavirenz Alone Efavirenz With Fenofibric Acid
Hide Arm/Group Description:
On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
2,461.58  (655.13) 2,384.79  (573.73)
2.Primary Outcome
Title Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
Hide Description 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.
Time Frame serial pharmacokinetic blood samples drawn 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
30 subjects were exposed to study drugs. A total of 6 subjects withdrew. One of those 6 subjects completed all dosing of study medications but withdrew consent prior to the 8 hour post-dose activities on Day 31.
Arm/Group Title Efavirenz Alone Efavirenz With Fenofibric Acid
Hide Arm/Group Description:
On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng-hr/mL
70,144.35  (18,004.09) 63,313.23  (21,446.35)
3.Primary Outcome
Title Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
Hide Description 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 for efavirenz.
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
30 subjects were exposed to study drugs. A total of 6 subjects withdrew. One of those 6 subjects completed all dosing of study medications but withdrew consent prior to the 8 hour post-dose activities on Day 31.
Arm/Group Title Efavirenz Alone Efavirenz With Fenofibric Acid
Hide Arm/Group Description:
On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: ng-hr/mL
106,689.60  (27,178.11) 96,382.08  (35,449.72)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Efavirenz Alone Fenofibric Acid Alone Efavirenz and Fenofibric Acid
Hide Arm/Group Description On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
All-Cause Mortality
Efavirenz Alone Fenofibric Acid Alone Efavirenz and Fenofibric Acid
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Efavirenz Alone Fenofibric Acid Alone Efavirenz and Fenofibric Acid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/28 (0.00%)      0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Efavirenz Alone Fenofibric Acid Alone Efavirenz and Fenofibric Acid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12      7      8    
Ear and labyrinth disorders       
Tinnitus   1/30 (3.33%)  1 0/28 (0.00%)  0 0/25 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain upper   0/30 (0.00%)  0 0/28 (0.00%)  0 1/25 (4.00%)  1
Diarrhea   1/30 (3.33%)  1 0/28 (0.00%)  0 0/25 (0.00%)  0
Nausea   2/30 (6.67%)  2 1/28 (3.57%)  1 2/25 (8.00%)  2
Retching   0/30 (0.00%)  0 1/28 (3.57%)  1 0/25 (0.00%)  0
Stomach discomfort   0/30 (0.00%)  0 0/28 (0.00%)  0 2/25 (8.00%)  2
Vomiting   0/30 (0.00%)  0 2/28 (7.14%)  2 1/25 (4.00%)  1
General disorders       
Chest pain   0/30 (0.00%)  0 1/28 (3.57%)  1 0/25 (0.00%)  0
Feeling cold   1/30 (3.33%)  1 0/28 (0.00%)  0 0/25 (0.00%)  0
Pain   0/30 (0.00%)  0 1/28 (3.57%)  1 0/25 (0.00%)  0
Pyrexia   0/30 (0.00%)  0 1/28 (3.57%)  1 1/25 (4.00%)  1
Upper respiratory tract infection   1/30 (3.33%)  1 0/28 (0.00%)  0 0/25 (0.00%)  0
Infections and infestations       
Sinusitis   0/30 (0.00%)  0 1/28 (3.57%)  1 0/25 (0.00%)  0
Investigations       
Alanine aminotransferase increased   0/30 (0.00%)  0 0/28 (0.00%)  0 1/25 (4.00%)  1
Aspartate aminotransferase increased   0/30 (0.00%)  0 0/28 (0.00%)  0 1/25 (4.00%)  1
Musculoskeletal and connective tissue disorders       
Myalgia   0/30 (0.00%)  0 0/28 (0.00%)  0 1/25 (4.00%)  1
Sensation of heaviness   0/30 (0.00%)  0 0/28 (0.00%)  0 1/25 (4.00%)  1
Nervous system disorders       
Dizziness   9/30 (30.00%)  9 1/28 (3.57%)  1 8/25 (32.00%)  8
Headache   4/30 (13.33%)  4 2/28 (7.14%)  2 4/25 (16.00%)  4
Somnolence   1/30 (3.33%)  1 0/28 (0.00%)  0 0/25 (0.00%)  0
Tremor   1/30 (3.33%)  1 0/28 (0.00%)  0 0/25 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dry throat   0/30 (0.00%)  0 0/28 (0.00%)  0 1/25 (4.00%)  1
Nasal congestion   1/30 (3.33%)  1 0/28 (0.00%)  0 0/25 (0.00%)  0
Pharyngolaryngeal pain   1/30 (3.33%)  1 1/28 (3.57%)  1 1/25 (4.00%)  1
Skin and subcutaneous tissue disorders       
Cold sweat   0/30 (0.00%)  0 0/28 (0.00%)  0 1/25 (4.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Medical Director
Organization: Mutual Pharmaceutical Company, Inc.
Phone: 215-697-1743
Responsible Party: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00960570     History of Changes
Other Study ID Numbers: MPC-028-08-1018
R08-0056
First Submitted: August 14, 2009
First Posted: August 18, 2009
Results First Submitted: August 20, 2009
Results First Posted: October 14, 2009
Last Update Posted: August 7, 2012