Trial Outcomes & Findings for A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247) (NCT NCT01622673)
NCT ID: NCT01622673
Last Updated: 2017-03-21
Results Overview
Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when coadministered with TUMS® or MINTOX®.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
12 hours postdose
Results posted on
2017-03-21
Participant Flow
Participant milestones
| Measure |
RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL
Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
|
TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL
Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
|
MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL
Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
|
RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL
Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
|
TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL
Participants received TUMS® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
|
MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL
Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
4
|
5
|
4
|
6
|
4
|
4
|
|
Treatment Period 1
COMPLETED
|
4
|
4
|
4
|
5
|
4
|
4
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Treatment Period 2
STARTED
|
4
|
4
|
4
|
5
|
4
|
4
|
|
Treatment Period 2
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 3
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Treatment Period 3
COMPLETED
|
4
|
3
|
4
|
4
|
4
|
4
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 4
STARTED
|
4
|
3
|
4
|
4
|
4
|
4
|
|
Treatment Period 4
COMPLETED
|
4
|
3
|
4
|
4
|
4
|
4
|
|
Treatment Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 5
STARTED
|
4
|
3
|
4
|
4
|
4
|
4
|
|
Treatment Period 5
COMPLETED
|
4
|
3
|
4
|
4
|
4
|
4
|
|
Treatment Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL
Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
|
TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL
Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
|
MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL
Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
|
RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL
Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
|
TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL
Participants received TUMS® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
|
MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL
Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 1
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 3
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247)
Baseline characteristics by cohort
| Measure |
RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL
n=4 Participants
Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
|
TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL
n=5 Participants
Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
|
MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL
n=4 Participants
Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
|
RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL
n=6 Participants
Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
|
TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL
n=4 Participants
Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
|
MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL
n=4 Participants
Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
46.6 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
36.8 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
40.3 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
39.8 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
40.8 years
STANDARD_DEVIATION 11.6 • n=10 Participants
|
41.3 years
STANDARD_DEVIATION 10.7 • n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 12 hours postdosePopulation: All participants were included for whom at least one pharmacokinetic (PK) parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics
Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when coadministered with TUMS® or MINTOX®.
Outcome measures
| Measure |
Raltegravir
n=26 Participants
Raltegravir 400 mg every 12 hours
|
TUMS® + Raltegravir
n=24 Participants
Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of pharmacokinetic (PK) sampling
|
MINTOX® + Raltegravir
n=25 Participants
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
|
MINTOX® Before Raltegravir
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
|
MINTOX® After Raltegravir
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
|
|---|---|---|---|---|---|
|
Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
|
132.30 nM
95% Confidence Interval 112 • Interval 101.14 to 173.05
|
89.75 nM
95% Confidence Interval 134 • Interval 68.08 to 118.32
|
49.38 nM
95% Confidence Interval 32.6 • Interval 37.62 to 64.81
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 hours postdosePopulation: All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics
Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when administered 2 hours before or after MINTOX®.
Outcome measures
| Measure |
Raltegravir
n=26 Participants
Raltegravir 400 mg every 12 hours
|
TUMS® + Raltegravir
n=23 Participants
Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of pharmacokinetic (PK) sampling
|
MINTOX® + Raltegravir
n=23 Participants
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
|
MINTOX® Before Raltegravir
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
|
MINTOX® After Raltegravir
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
|
|---|---|---|---|---|---|
|
Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
|
125.75 nM
Interval 94.33 to 167.62
|
54.92 nM
Interval 41.36 to 72.91
|
54.47 nM
Interval 40.95 to 72.46
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdosePopulation: All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics
Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when coadministered with TUMS® or MINTOX®.
Outcome measures
| Measure |
Raltegravir
n=26 Participants
Raltegravir 400 mg every 12 hours
|
TUMS® + Raltegravir
n=24 Participants
Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of pharmacokinetic (PK) sampling
|
MINTOX® + Raltegravir
n=25 Participants
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
|
MINTOX® Before Raltegravir
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
|
MINTOX® After Raltegravir
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
|
|---|---|---|---|---|---|
|
Least Squares Mean Steady State Area Under the Plasma Concentration-time Curve (AUC0-12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
|
16399.76 nM*hr
95% Confidence Interval 12300 • Interval 12728.79 to 21129.44
|
7294.30 nM*hr
95% Confidence Interval 6690 • Interval 5613.53 to 9478.31
|
8358.67 nM*hr
95% Confidence Interval 5040 • Interval 6456.83 to 10820.68
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdosePopulation: All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics
Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when administered 2 hours before or after MINTOX®.
Outcome measures
| Measure |
Raltegravir
n=26 Participants
Raltegravir 400 mg every 12 hours
|
TUMS® + Raltegravir
n=23 Participants
Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of pharmacokinetic (PK) sampling
|
MINTOX® + Raltegravir
n=23 Participants
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
|
MINTOX® Before Raltegravir
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
|
MINTOX® After Raltegravir
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
|
|---|---|---|---|---|---|
|
Least Squares Mean Steady State Area Under the Plasma Concentration-Time (AUC0-12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
|
17577.15 nM*hr
Interval 13353.74 to 23136.29
|
8521.95 nM*hr
Interval 5572.42 to 13032.7
|
12226.11 nM*hr
Interval 7988.11 to 18712.53
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdosePopulation: All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics
Participant blood samples were collected to measure the steady state maximum plasma concentration of raltegravir when administered alone or with a single dose of antacid. The primary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when coadministered with TUMS® or MINTOX®.
Outcome measures
| Measure |
Raltegravir
n=26 Participants
Raltegravir 400 mg every 12 hours
|
TUMS® + Raltegravir
n=24 Participants
Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of pharmacokinetic (PK) sampling
|
MINTOX® + Raltegravir
n=25 Participants
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
|
MINTOX® Before Raltegravir
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
|
MINTOX® After Raltegravir
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
|
|---|---|---|---|---|---|
|
Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)
|
5427.15 nM
95% Confidence Interval 4530 • Interval 4132.93 to 7126.66
|
2584.78 nM
95% Confidence Interval 1700 • Interval 1949.15 to 3427.7
|
3013.88 nM
95% Confidence Interval 1940 • Interval 2282.54 to 3979.54
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdosePopulation: All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics
Participant blood samples were collected to measure the maximum steady state plasma concentration of raltegravir after administration alone or before or after a single dose of antiacid. The secondary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when administered 2 hours before or after MINTOX®.
Outcome measures
| Measure |
Raltegravir
n=26 Participants
Raltegravir 400 mg every 12 hours
|
TUMS® + Raltegravir
n=23 Participants
Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of pharmacokinetic (PK) sampling
|
MINTOX® + Raltegravir
n=23 Participants
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
|
MINTOX® Before Raltegravir
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
|
MINTOX® After Raltegravir
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
|
|---|---|---|---|---|---|
|
Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)
|
5678.90 nM
Interval 4263.73 to 7563.78
|
2753.64 nM
Interval 1689.26 to 4488.68
|
4399.66 nM
Interval 2698.18 to 7174.09
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdosePopulation: All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics
Participant blood samples were collected to measure the time to achieve the maximum steady state plasma concentration of raltegravir when administered alone or with a single dose of antacid
Outcome measures
| Measure |
Raltegravir
n=26 Participants
Raltegravir 400 mg every 12 hours
|
TUMS® + Raltegravir
n=24 Participants
Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of pharmacokinetic (PK) sampling
|
MINTOX® + Raltegravir
n=25 Participants
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
|
MINTOX® Before Raltegravir
n=23 Participants
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
|
MINTOX® After Raltegravir
n=23 Participants
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
|
|---|---|---|---|---|---|
|
Mean Time to Maximum Plasma Concentration (Tmax) of Raltegravir
|
2.06 hr
Standard Deviation 1.23
|
2.08 hr
Standard Deviation 1.64
|
1.48 hr
Standard Deviation 0.94
|
1.52 hr
Standard Deviation 1.17
|
1.78 hr
Standard Deviation 1.37
|
PRIMARY outcome
Timeframe: Up to 7 days after the last dose of study drugPopulation: All subjects who received any amount of the study drug were included in the safety population
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.
Outcome measures
| Measure |
Raltegravir
n=26 Participants
Raltegravir 400 mg every 12 hours
|
TUMS® + Raltegravir
n=25 Participants
Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of pharmacokinetic (PK) sampling
|
MINTOX® + Raltegravir
n=25 Participants
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
|
MINTOX® Before Raltegravir
n=23 Participants
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
|
MINTOX® After Raltegravir
n=23 Participants
Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
|
|---|---|---|---|---|---|
|
Number of Participants With Any Clinical or Laboratory Adverse Event (AE)
|
1 participants
|
2 participants
|
2 participants
|
2 participants
|
1 participants
|
Adverse Events
Raltegravir
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TUMS® + Raltegravir
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MINTOX® + Raltegravir
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MINTOX® Before Raltegravir
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MINTOX® After Raltegravir
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER