Trial Outcomes & Findings for A Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz (NCT NCT01472380)
NCT ID: NCT01472380
Last Updated: 2012-08-01
Results Overview
The maximum or peak concentration that the drug reaches in the plasma for efavirenz
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
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
Results posted on
2012-08-01
Participant Flow
Thirty (30) healthy, non-smoking adult male and female volunteers from the community at-large were enrolled
Participant milestones
| Measure |
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
|
|---|---|
|
Efavirenz Alone
STARTED
|
30
|
|
Efavirenz Alone
COMPLETED
|
29
|
|
Efavirenz Alone
NOT COMPLETED
|
1
|
|
Fenofibric Acid (FFA) Alone
STARTED
|
29
|
|
Fenofibric Acid (FFA) Alone
COMPLETED
|
29
|
|
Fenofibric Acid (FFA) Alone
NOT COMPLETED
|
0
|
|
1 Day Period Between Dosing
STARTED
|
29
|
|
1 Day Period Between Dosing
COMPLETED
|
28
|
|
1 Day Period Between Dosing
NOT COMPLETED
|
1
|
|
Efavirenz and FFA
STARTED
|
28
|
|
Efavirenz and FFA
COMPLETED
|
28
|
|
Efavirenz and FFA
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Efavirenz Alone
Withdrawal by Subject
|
1
|
|
1 Day Period Between Dosing
Protocol Violation
|
1
|
Baseline Characteristics
A Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz
Baseline characteristics by cohort
| Measure |
Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together
n=30 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age Continuous
|
26.8 years
STANDARD_DEVIATION 7.0 • n=93 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: 28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the maximum concentration (Cmax)for efavirenz.
The maximum or peak concentration that the drug reaches in the plasma for efavirenz
Outcome measures
| Measure |
Efavirenz Alone
n=28 Participants
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
n=28 Participants
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.
|
|---|---|---|
|
Pharmacokinetics: Maximum Plasma Concentration (Cmax)
|
2.62 ug/mL
Standard Deviation 0.57
|
2.63 ug/mL
Standard Deviation 0.55
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: 28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the area under the plasma concentration versus time curve from time 0 to the time t of the last quantifiable concentration (AUC0-t) for efavirenz.
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
Outcome measures
| Measure |
Efavirenz Alone
n=28 Participants
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
n=28 Participants
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.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 to Time t[AUC(0-t)]
|
70.58 h*ug/mL
Standard Deviation 17.28
|
64.62 h*ug/mL
Standard Deviation 15.22
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: 28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the area under the plasma concentration versus time curve from time 0 to infinity for efavirenz.
The area under the plasma concentration versus time curve from time 0 to infinity. \[AUC(0 to infinity)\] 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.
Outcome measures
| Measure |
Efavirenz Alone
n=28 Participants
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
n=28 Participants
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.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-infinity]
|
121 h*ug/mL
Standard Deviation 33.6
|
112 h*ug/mL
Standard Deviation 30.3
|
Adverse Events
Efavirenz Alone
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Fenofibric Acid Alone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Efavirenz With Fenofibric Acid
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Efavirenz Alone
n=30 participants at risk
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.
|
Fenofibric Acid Alone
n=29 participants at risk
On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals.
|
Efavirenz With Fenofibric Acid
n=28 participants at risk
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.
|
|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/30
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/30
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • Number of events 2
|
0.00%
0/29
|
0.00%
0/28
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Number of events 1
|
0.00%
0/29
|
0.00%
0/28
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/30
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/30
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
|
Investigations
Blood pressure increased
|
3.3%
1/30 • Number of events 1
|
0.00%
0/29
|
0.00%
0/28
|
|
Nervous system disorders
Dizziness
|
50.0%
15/30 • Number of events 17
|
0.00%
0/29
|
28.6%
8/28 • Number of events 8
|
|
Nervous system disorders
Headache
|
20.0%
6/30 • Number of events 6
|
6.9%
2/29 • Number of events 2
|
21.4%
6/28 • Number of events 6
|
|
Nervous system disorders
Somnolence
|
3.3%
1/30 • Number of events 1
|
0.00%
0/29
|
0.00%
0/28
|
|
Psychiatric disorders
Euphoric Mood
|
0.00%
0/30
|
0.00%
0/29
|
17.9%
5/28 • Number of events 5
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
3.3%
1/30 • Number of events 1
|
0.00%
0/29
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.3%
1/30 • Number of events 1
|
0.00%
0/29
|
0.00%
0/28
|
|
Vascular disorders
Hot flush
|
0.00%
0/30
|
0.00%
0/29
|
14.3%
4/28 • Number of events 4
|
Additional Information
VP, Clinical Development and Medical Affairs
Mutual Pharmaceutical Company, Inc.
Phone: 215-697-1743
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60