Trial Outcomes & Findings for A Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects (NCT NCT00666705)
NCT ID: NCT00666705
Last Updated: 2013-01-25
Results Overview
Effect of raltegravir on pharmacokinetics of maraviroc (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir).
COMPLETED
PHASE4
18 participants
Days 11 and 14
2013-01-25
Participant Flow
One site in the United States
Subjects were to be healthy male or female subjects between the ages of 18 and 55 years, inclusive. Subjects were required to meet all eligibility criteria prior to randomization into the study.
Participant milestones
| Measure |
Maraviroc / Raltegravir (Alone and Co-administered)
All subjects received the following fixed sequence study treatments:
Days 1-3: raltegravir 400 milligrams (mg) every 12 hours (AM dose on Day 3) Days 4-5: washout Days 6-11: maraviroc 300 mg every 12 hours Days 12-14: raltegravir 400 mg every 12 hours and maraviroc 300 mg every 12 hours (AM doses on Day 14).
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
Raltegravir Alone (Days 1 - 3)
|
18
|
|
Overall Study
Washout (Days 4 - 5)
|
18
|
|
Overall Study
Maraviroc Alone (Days 6 - 11)
|
18
|
|
Overall Study
Raltegravir + Maraviroc (Days 12 - 14)
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Maraviroc / Raltegravir (Alone and Co-administered)
All subjects received the following fixed sequence study treatments:
Days 1-3: raltegravir 400 milligrams (mg) every 12 hours (AM dose on Day 3) Days 4-5: washout Days 6-11: maraviroc 300 mg every 12 hours Days 12-14: raltegravir 400 mg every 12 hours and maraviroc 300 mg every 12 hours (AM doses on Day 14).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects
Baseline characteristics by cohort
| Measure |
Maraviroc / Raltegravir (Alone and Co-administered)
n=18 Participants
All subjects received the following fixed sequence study treatments:
Days 1-3: raltegravir 400 mg every 12 hours (AM dose on Day 3) Days 4-5: washout Days 6-11: maraviroc 300 mg every 12 hours Days 12-14: raltegravir 400 mg every 12 hours and maraviroc 300 mg every 12 hours (AM doses on Day 14).
|
|---|---|
|
Age Continuous
|
36.3 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Days 11 and 14Population: The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.
Effect of raltegravir on pharmacokinetics of maraviroc (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir).
Outcome measures
| Measure |
Maraviroc + Raltegravir (Test)
n=17 Participants
On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
|
Maraviroc (Reference)
n=17 Participants
300 mg every 12 hours on Study Days 6-11
|
|---|---|---|
|
Maraviroc Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)
|
2551.9 ng.hr/mL
Standard Deviation 786.68
|
2971.6 ng.hr/mL
Standard Deviation 841.65
|
PRIMARY outcome
Timeframe: Days 11 and 14Population: The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.
Effect of raltegravir on pharmacokinetics of maraviroc (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.
Outcome measures
| Measure |
Maraviroc + Raltegravir (Test)
n=17 Participants
On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
|
Maraviroc (Reference)
n=17 Participants
300 mg every 12 hours on Study Days 6-11
|
|---|---|---|
|
Maraviroc Pharmacokinetic (PK) Parameter: Maximum Concentration (Cmax)
|
691.6 ng/mL
Standard Deviation 322.24
|
851.4 ng/mL
Standard Deviation 349.38
|
PRIMARY outcome
Timeframe: Days 3 and 14Population: The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.
Effect of maraviroc on pharmacokinetics of raltegravir (comparison of AUCτ of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir).
Outcome measures
| Measure |
Maraviroc + Raltegravir (Test)
n=17 Participants
On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
|
Maraviroc (Reference)
n=18 Participants
300 mg every 12 hours on Study Days 6-11
|
|---|---|---|
|
Raltegravir Pharmacokinetics (PK) Parameter: Area Under the Plasma Concentration-time Profile Over the Dosing Interval (AUCτ)
|
6287.5 ng.hr/mL
Standard Deviation 3979.30
|
9122.4 ng.hr/mL
Standard Deviation 5311.34
|
PRIMARY outcome
Timeframe: Days 3 and 14Population: The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.
Effect of maraviroc on pharmacokinetics of raltegravir (comparison of Cmax of raltegravir co-administered with maraviroc (Test) versus raltegravir administered alone (Reference)). Pharmacokinetics assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). Cmax is the maximum plasma concentration.
Outcome measures
| Measure |
Maraviroc + Raltegravir (Test)
n=17 Participants
On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
|
Maraviroc (Reference)
n=18 Participants
300 mg every 12 hours on Study Days 6-11
|
|---|---|---|
|
Raltegravir Pharmacokinetics (PK) Parameter: Maximum Concentration (Cmax)
|
2169.6 ng/mL
Standard Deviation 1570.58
|
3026.6 ng/mL
Standard Deviation 2030.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 11 and 14Population: The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.
Effect of raltegravir on pharmacokinetics of maraviroc (comparison of C12 of raltegravir co-administered with maraviroc (Test) versus maraviroc administered alone (Reference)). Pharmacokinetics were assessed on Day 11 (maraviroc) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.
Outcome measures
| Measure |
Maraviroc + Raltegravir (Test)
n=17 Participants
On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
|
Maraviroc (Reference)
n=17 Participants
300 mg every 12 hours on Study Days 6-11
|
|---|---|---|
|
Maraviroc Pharmacokinetic (PK) Parameter: 12-Hour Trough Concentration (C12)
|
48.34 ng/mL
Standard Deviation 13.70
|
53.36 ng/mL
Standard Deviation 14.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 3 and 14Population: The Pharmacokinetic (PK) parameter analysis population is defined as all subjects enrolled and treated who have at least one of the PK parameters of primary interest in at least one treatment period.
Effect of maraviroc on pharmacokinetics of raltegravir (comparison of C12 of raltegravir co-administered with maraviroc (Test) vs. raltegravir administered alone (Reference)). Pharmacokinetics were assessed on Day 3 (raltegravir) and Day 14 (maraviroc and raltegravir). C12 is the 12-hour trough concentration.
Outcome measures
| Measure |
Maraviroc + Raltegravir (Test)
n=17 Participants
On Study Days 12-14: Raltegravir 400 mg every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
|
Maraviroc (Reference)
n=18 Participants
300 mg every 12 hours on Study Days 6-11
|
|---|---|---|
|
Raltegravir Pharmacokinetics (PK) Parameter: 12-Hour Trough Concentration (C12)
|
51.16 ng/mL
Standard Deviation 22.64
|
73.69 ng/mL
Standard Deviation 36.21
|
Adverse Events
Maraviroc
Maraviroc + Raltegravir
Raltegravir
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Maraviroc
n=18 participants at risk
300 milligrams (mg) every 12 hours on Study Days 6-11
|
Maraviroc + Raltegravir
n=17 participants at risk
On Study Days 12-14: Raltegravir 400 milligrams (mg) every 12 hours, maraviroc 300 mg every 12 hours (AM doses only on Day 14)
|
Raltegravir
n=18 participants at risk
400 milligrams (mg) every 12 hours on Study Days 1-3 Followed by washout on Study Days 4-5
|
|---|---|---|---|
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Gastrointestinal disorders
Constipation
|
5.6%
1/18
|
0.00%
0/17
|
0.00%
0/18
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18
|
5.9%
1/17
|
0.00%
0/18
|
|
Infections and infestations
Folliculitis
|
5.6%
1/18
|
0.00%
0/17
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18
|
5.9%
1/17
|
0.00%
0/18
|
|
Nervous system disorders
Headache
|
0.00%
0/18
|
5.9%
1/17
|
11.1%
2/18
|
|
Nervous system disorders
Peripheral neurophathy
|
5.6%
1/18
|
5.9%
1/17
|
5.6%
1/18
|
|
Nervous system disorders
Somnolence
|
5.6%
1/18
|
5.9%
1/17
|
0.00%
0/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER