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Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirty (30) healthy, non-smoking adult male and female volunteers from the community at-large were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Forty-nine (49) subjects were screened. Nineteen (19) were screen failures.

Reporting Groups
  Description
Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA 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.

Participant Flow for 5 periods

Period 1:   Efavirenz Alone
    Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA
STARTED   30 
COMPLETED   30 
NOT COMPLETED   0 

Period 2:   21 Day Washout Period
    Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA
STARTED   30 
COMPLETED   28 
NOT COMPLETED   2 
Adverse Event                1 
Withdrawal by Subject                1 

Period 3:   Fenofibric Acid Alone
    Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA
STARTED   28 
COMPLETED   28 
NOT COMPLETED   0 

Period 4:   1 Day Period Between Dosing
    Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA
STARTED   28 
COMPLETED   25 
NOT COMPLETED   3 
Adverse Event                2 
Withdrawal by Subject                1 

Period 5:   Efavirenz and Fenofibric Acid
    Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA
STARTED   25 
COMPLETED   25 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA 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.

Baseline Measures
   Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   30 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.8  (6.4) 
Gender 
[Units: Participants]
 
Female   13 
Male   17 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   3 
White   27 
More than one race   0 
Unknown or Not Reported   0 


  Outcome Measures

1.  Primary:   Maximum Plasma Concentration (Cmax) of 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. ]

2.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]   [ 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 ]

3.  Primary:   Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]   [ 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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: clinicaltrials@urlmutual.com



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