Trial Outcomes & Findings for Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz (NCT NCT00960570)
NCT ID: NCT00960570
Last Updated: 2012-08-07
Results Overview
The maximum or peak concentration that efavirenz reaches in the plasma.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
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.
Results posted on
2012-08-07
Participant Flow
Thirty (30) healthy, non-smoking adult male and female volunteers from the community at-large were enrolled.
Forty-nine (49) subjects were screened. Nineteen (19) were screen failures.
Participant milestones
| Measure |
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.
|
|---|---|
|
Efavirenz Alone
STARTED
|
30
|
|
Efavirenz Alone
COMPLETED
|
30
|
|
Efavirenz Alone
NOT COMPLETED
|
0
|
|
21 Day Washout Period
STARTED
|
30
|
|
21 Day Washout Period
COMPLETED
|
28
|
|
21 Day Washout Period
NOT COMPLETED
|
2
|
|
Fenofibric Acid Alone
STARTED
|
28
|
|
Fenofibric Acid Alone
COMPLETED
|
28
|
|
Fenofibric Acid Alone
NOT COMPLETED
|
0
|
|
1 Day Period Between Dosing
STARTED
|
28
|
|
1 Day Period Between Dosing
COMPLETED
|
25
|
|
1 Day Period Between Dosing
NOT COMPLETED
|
3
|
|
Efavirenz and Fenofibric Acid
STARTED
|
25
|
|
Efavirenz and Fenofibric Acid
COMPLETED
|
25
|
|
Efavirenz and Fenofibric Acid
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
21 Day Washout Period
Adverse Event
|
1
|
|
21 Day Washout Period
Withdrawal by Subject
|
1
|
|
1 Day Period Between Dosing
Adverse Event
|
2
|
|
1 Day Period Between Dosing
Withdrawal by Subject
|
1
|
Baseline Characteristics
Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz
Baseline characteristics by cohort
| Measure |
Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA
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=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
26.8 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 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 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.Population: 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.
The maximum or peak concentration that efavirenz reaches in the plasma.
Outcome measures
| Measure |
Efavirenz Alone
n=24 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=24 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.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Efavirenz
|
2,461.58 ng/mL
Standard Deviation 655.13
|
2,384.79 ng/mL
Standard Deviation 573.73
|
PRIMARY outcome
Timeframe: 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 administrationPopulation: 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.
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=24 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=24 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.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
|
70,144.35 ng-hr/mL
Standard Deviation 18,004.09
|
63,313.23 ng-hr/mL
Standard Deviation 21,446.35
|
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: 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.
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.
Outcome measures
| Measure |
Efavirenz Alone
n=24 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=24 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.
|
|---|---|---|
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
|
106,689.60 ng-hr/mL
Standard Deviation 27,178.11
|
96,382.08 ng-hr/mL
Standard Deviation 35,449.72
|
Adverse Events
Efavirenz Alone
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Fenofibric Acid Alone
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Efavirenz and Fenofibric Acid
Serious events: 0 serious events
Other events: 8 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=28 participants at risk
On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals.
|
Efavirenz and Fenofibric Acid
n=25 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.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
3.3%
1/30 • Number of events 1
|
0.00%
0/28
|
0.00%
0/25
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/30
|
0.00%
0/28
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1
|
0.00%
0/28
|
0.00%
0/25
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • Number of events 2
|
3.6%
1/28 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/30
|
3.6%
1/28 • Number of events 1
|
0.00%
0/25
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/30
|
0.00%
0/28
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/30
|
7.1%
2/28 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Chest pain
|
0.00%
0/30
|
3.6%
1/28 • Number of events 1
|
0.00%
0/25
|
|
General disorders
Feeling cold
|
3.3%
1/30 • Number of events 1
|
0.00%
0/28
|
0.00%
0/25
|
|
General disorders
Pain
|
0.00%
0/30
|
3.6%
1/28 • Number of events 1
|
0.00%
0/25
|
|
General disorders
Pyrexia
|
0.00%
0/30
|
3.6%
1/28 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.00%
0/30
|
3.6%
1/28 • Number of events 1
|
0.00%
0/25
|
|
General disorders
Upper respiratory tract infection
|
3.3%
1/30 • Number of events 1
|
0.00%
0/28
|
0.00%
0/25
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/30
|
0.00%
0/28
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/30
|
0.00%
0/28
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/30
|
0.00%
0/28
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/30
|
0.00%
0/28
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
30.0%
9/30 • Number of events 9
|
3.6%
1/28 • Number of events 1
|
32.0%
8/25 • Number of events 8
|
|
Nervous system disorders
Headache
|
13.3%
4/30 • Number of events 4
|
7.1%
2/28 • Number of events 2
|
16.0%
4/25 • Number of events 4
|
|
Nervous system disorders
Somnolence
|
3.3%
1/30 • Number of events 1
|
0.00%
0/28
|
0.00%
0/25
|
|
Nervous system disorders
Tremor
|
3.3%
1/30 • Number of events 1
|
0.00%
0/28
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/30
|
0.00%
0/28
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.3%
1/30 • Number of events 1
|
0.00%
0/28
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.3%
1/30 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/30
|
0.00%
0/28
|
4.0%
1/25 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60