Trial Outcomes & Findings for A Pharmacokinetic Study to Evaluate the Effect of MAALOX on Raltegravir (MK-0518) in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-295) (NCT NCT01930045)
NCT ID: NCT01930045
Last Updated: 2018-08-24
Results Overview
Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
12 hours after dosing on Day 1 of each period
Results posted on
2018-08-24
Participant Flow
Participant milestones
| Measure |
Ralt-MAL4Ralt-Ralt4MAL-MAL6Ralt-Ralt6MAL
Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Raltegravir (Ralt) alone in Period 1, MAALOX (MAL) followed 4 hrs later by Ralt in Period 2, Ralt followed 4 hrs later by MAL in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
|
MAL4Ralt-Ralt4MAL-Ralt-MAL6Ralt-Ralt6MAL
Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt followed 4 hrs later by MAL in Period 2, Ralt alone in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
|
Ralt4MAL-Ralt-MAL4Ralt-MAL6Ralt-Ralt6MAL
Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, Ralt alone in Period 2, MAL followed 4 hrs later by Ralt in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
|
Ralt-Ralt4MAL-MAL4Ralt-Ralt6MAL-MAL6Ralt
Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt alone in Period 1, Ralt followed 4 hrs later by MAL in Period 2, MAL followed 4 hrs later by Ralt in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
|
MAL4Ralt-Ralt-Ralt4MAL-Ralt6MAL-MAL6Ralt
Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt alone in Period 2, Ralt followed 4 hrs later by MAL in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
|
Ralt4MAL-MAL4Ralt-Ralt-Ralt6MAL-MAL6Ralt
Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, MAL followed 4 hrs later by Ralt in Period 2, Ralt alone in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
|
|---|---|---|---|---|---|---|
|
Part 1 - Period 1
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Part 1 - Period 1
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Part 1 - Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Period 2
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Part 1 - Period 2
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Part 1 - Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 - Period 3
STARTED
|
3
|
3
|
2
|
3
|
3
|
3
|
|
Part 1 - Period 3
COMPLETED
|
3
|
3
|
2
|
3
|
3
|
3
|
|
Part 1 - Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Pause (up to 37 Days)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Pause (up to 37 Days)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
1
|
|
Pause (up to 37 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Part 2 - Period 4
STARTED
|
3
|
3
|
3
|
3
|
3
|
1
|
|
Part 2 - Period 4
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
1
|
|
Part 2 - Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 - Period 5
STARTED
|
3
|
3
|
3
|
3
|
3
|
1
|
|
Part 2 - Period 5
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
1
|
|
Part 2 - Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Ralt-MAL4Ralt-Ralt4MAL-MAL6Ralt-Ralt6MAL
Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Raltegravir (Ralt) alone in Period 1, MAALOX (MAL) followed 4 hrs later by Ralt in Period 2, Ralt followed 4 hrs later by MAL in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
|
MAL4Ralt-Ralt4MAL-Ralt-MAL6Ralt-Ralt6MAL
Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt followed 4 hrs later by MAL in Period 2, Ralt alone in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
|
Ralt4MAL-Ralt-MAL4Ralt-MAL6Ralt-Ralt6MAL
Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, Ralt alone in Period 2, MAL followed 4 hrs later by Ralt in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
|
Ralt-Ralt4MAL-MAL4Ralt-Ralt6MAL-MAL6Ralt
Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt alone in Period 1, Ralt followed 4 hrs later by MAL in Period 2, MAL followed 4 hrs later by Ralt in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
|
MAL4Ralt-Ralt-Ralt4MAL-Ralt6MAL-MAL6Ralt
Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt alone in Period 2, Ralt followed 4 hrs later by MAL in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
|
Ralt4MAL-MAL4Ralt-Ralt-Ralt6MAL-MAL6Ralt
Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, MAL followed 4 hrs later by Ralt in Period 2, Ralt alone in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
|
|---|---|---|---|---|---|---|
|
Pause (up to 37 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Pause (up to 37 Days)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Pharmacokinetic Study to Evaluate the Effect of MAALOX on Raltegravir (MK-0518) in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-295)
Baseline characteristics by cohort
| Measure |
All Participants
n=18 Participants
All enrolled participants
|
|---|---|
|
Age, Continuous
|
48.7 Years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 hours after dosing on Day 1 of each periodPopulation: The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.
Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.
Outcome measures
| Measure |
Raltegravir
n=18 Participants
400 mg Raltegravir alone
|
Maalox → 4 Hours → Raltegravir
n=17 Participants
20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
|
Raltegravir → 4 Hours → Maalox
n=18 Participants
400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
|
|---|---|---|---|
|
Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 1
|
241.35 nM
Interval 177.31 to 328.52
|
96.29 nM
Interval 73.48 to 126.18
|
92.22 nM
Interval 72.31 to 117.6
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each periodPopulation: The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.
Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir in order to determine the geometric mean area under the curve plasma concentration versus time.
Outcome measures
| Measure |
Raltegravir
n=18 Participants
400 mg Raltegravir alone
|
Maalox → 4 Hours → Raltegravir
n=17 Participants
20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
|
Raltegravir → 4 Hours → Maalox
n=18 Participants
400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 1
|
17055.21 hr.nM
Interval 11625.3 to 25021.3
|
13881.87 hr.nM
Interval 9703.09 to 19860.3
|
11602.02 hr.nM
Interval 7072.82 to 19031.55
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each periodPopulation: The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.
Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration.
Outcome measures
| Measure |
Raltegravir
n=18 Participants
400 mg Raltegravir alone
|
Maalox → 4 Hours → Raltegravir
n=17 Participants
20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
|
Raltegravir → 4 Hours → Maalox
n=18 Participants
400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
|
|---|---|---|---|
|
Maximum Plasma Concentration (C Max) of Raltegravir in Part 1
|
4723.00 nM
Interval 2837.48 to 7861.45
|
3690.96 nM
Interval 2321.28 to 5868.82
|
3324.84 nM
Interval 1829.19 to 6043.4
|
PRIMARY outcome
Timeframe: 12 hours after dosing on Day 1 of each periodPopulation: The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.
Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.
Outcome measures
| Measure |
Raltegravir
n=18 Participants
400 mg Raltegravir alone
|
Maalox → 4 Hours → Raltegravir
n=16 Participants
20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
|
Raltegravir → 4 Hours → Maalox
n=16 Participants
400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
|
|---|---|---|---|
|
Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 2
|
241.35 nM
Interval 178.78 to 325.83
|
121.52 nM
Interval 93.99 to 157.11
|
122.39 nM
Interval 101.28 to 147.9
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each periodPopulation: The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.
Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean area under the curve plasma concentration versus time.
Outcome measures
| Measure |
Raltegravir
n=18 Participants
400 mg Raltegravir alone
|
Maalox → 4 Hours → Raltegravir
n=16 Participants
20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
|
Raltegravir → 4 Hours → Maalox
n=16 Participants
400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 2
|
17055.21 hr.nM
Interval 11505.21 to 25282.47
|
14799.48 hr.nM
Interval 10295.71 to 21273.38
|
15104.15 hr.nM
Interval 10314.37 to 22118.22
|
PRIMARY outcome
Timeframe: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each periodPopulation: The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.
Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration.
Outcome measures
| Measure |
Raltegravir
n=18 Participants
400 mg Raltegravir alone
|
Maalox → 4 Hours → Raltegravir
n=16 Participants
20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
|
Raltegravir → 4 Hours → Maalox
n=16 Participants
400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
|
|---|---|---|---|
|
Maximum Plasma Concentration (C Max) of Raltegravir in Part 2
|
4723.00 nM
Interval 2825.62 to 7894.45
|
4268.72 nM
Interval 2660.89 to 6848.07
|
4256.01 nM
Interval 2587.69 to 6999.93
|
Adverse Events
Raltegravir
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Maalox → 4 Hours → Raltegravir
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Raltegravir → 4 Hours → Maalox
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Maalox → 6 Hours → Raltegravir
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Raltegravir → 6 Hours → Maalox
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Raltegravir
n=18 participants at risk
400 mg Raltegravir alone
|
Maalox → 4 Hours → Raltegravir
n=17 participants at risk
20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
|
Raltegravir → 4 Hours → Maalox
n=18 participants at risk
400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
|
Maalox → 6 Hours → Raltegravir
n=16 participants at risk
20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
|
Raltegravir → 6 Hours → Maalox
n=16 participants at risk
400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/18 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
0.00%
0/17 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
0.00%
0/18 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
6.2%
1/16 • Number of events 1 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
0.00%
0/16 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/18 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
5.9%
1/17 • Number of events 1 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
0.00%
0/18 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
0.00%
0/16 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
0.00%
0/16 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
0.00%
0/17 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
0.00%
0/18 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
6.2%
1/16 • Number of events 1 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
0.00%
0/16 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/18 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
0.00%
0/17 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
5.6%
1/18 • Number of events 1 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
0.00%
0/16 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
0.00%
0/16 • Up to 84 days
Participants who received at least one dose of the investigational drug. Adverse events are reported not by the sequence of treatments, but rather by the treatment administered at the time of the adverse event.
|
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 trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
- Publication restrictions are in place
Restriction type: OTHER