A Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz - Study Results

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Basic Science
Condition:	Healthy
Interventions:	Drug: efavirenz Drug: fenofibric acid 105 mg

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
No text entered.

Reporting Groups

	Description
Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together	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

Description

Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together

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 4 periods

Period 1: Efavirenz Alone

	Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together
STARTED	30
COMPLETED	29
NOT COMPLETED	1
Withdrawal by Subject	1

Period 2: Fenofibric Acid (FFA) Alone

	Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together
STARTED	29
COMPLETED	29
NOT COMPLETED	0

Period 3: 1 Day Period Between Dosing

	Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together
STARTED	29
COMPLETED	28
NOT COMPLETED	1
Protocol Violation	1

Period 4: Efavirenz and FFA

	Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together
STARTED	28
COMPLETED	28
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together	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

Description

Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together

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, FFA Alone, Enfavirenz and FFA Together
Number of Participants [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 ± 7.0
Gender [units: participants]
Female	16
Male	14
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	1
Not Hispanic or Latino	29
Unknown or Not Reported	0
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0
Asian	1
Native Hawaiian or Other Pacific Islander	1
Black or African American	3
White	24
More than one race	0
Unknown or Not Reported	1
Region of Enrollment [units: participants]
United States	30

Outcome Measures

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1. Primary:

Pharmacokinetics: Maximum Plasma Concentration (Cmax) [ Time Frame: serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration ]

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Measure Type	Primary
Measure Title	Pharmacokinetics: Maximum Plasma Concentration (Cmax)
Measure Description	The maximum or peak concentration that the drug reaches in the plasma for efavirenz
Time Frame	serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration
Safety Issue	No

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.
28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the maximum concentration (Cmax)for efavirenz.

Reporting Groups

	Description
Efavirenz Alone	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
Efavirenz With Fenofibric Acid	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.

Measured Values

	Efavirenz Alone	Efavirenz With Fenofibric Acid
Number of Participants Analyzed [units: participants]	28	28
Pharmacokinetics: Maximum Plasma Concentration (Cmax) [units: ug/mL] Mean ± Standard Deviation	2.62 ± 0.57	2.63 ± 0.55

No statistical analysis provided for Pharmacokinetics: Maximum Plasma Concentration (Cmax)

2. Primary:

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 to Time t[AUC(0-t)] [ Time Frame: serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration ]

Show Outcome Measure 2

3. Primary:

Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-infinity] [ 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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact:

Name/Title: VP, Clinical Development and Medical Affairs
Organization: Mutual Pharmaceutical Company, Inc.
phone: 215-697-1743
e-mail: clinicaltrials@urlmutual.com

No publications provided

Responsible Party:	Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:	NCT01472380 History of Changes
Other Study ID Numbers:	MPC-028-11-1001
Study First Received:	November 11, 2011
Results First Received:	June 15, 2012
Last Updated:	July 30, 2012
Health Authority:	United States: Food and Drug Administration