Trial Outcomes & Findings for A Study of MK-5720 in Participants With Schizophrenia (MK-5720-001) (NCT NCT05953740)
NCT ID: NCT05953740
Last Updated: 2025-03-04
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced one or more AEs is reported here for participants in Period 1. Per protocol, this outcome measure has been reported by panel and dose. As specified by the protocol, Period 2 has been analyzed separately and reported later in the record.
COMPLETED
PHASE1
17 participants
Up to approximately 10 days
2025-03-04
Participant Flow
Participants with schizophrenia were enrolled. Only participants in Panel A, Panel B, and dose-matched placebo were enrolled. Participants were not enrolled in Panels C, D, E, and F and no data was collected.
Participant milestones
| Measure |
Panel A: Period 1 MK-8189 4 mg → Period 2 MK-5720 35mg
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg → Period 2 MK-5720 70 mg
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1 → Placebo Period 2
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg → Period 2 MK-5720 140 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg → Period 2 MK-5720 280 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg → Period 2 MK-5720 560 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg → Period 2 MK-5720 560 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1 → Placebo Period 2
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
6
|
7
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Period 1
Treated
|
6
|
7
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Period 1
COMPLETED
|
6
|
6
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
6
|
6
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
COMPLETED
|
6
|
5
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Panel A: Period 1 MK-8189 4 mg → Period 2 MK-5720 35mg
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg → Period 2 MK-5720 70 mg
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1 → Placebo Period 2
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg → Period 2 MK-5720 140 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg → Period 2 MK-5720 280 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg → Period 2 MK-5720 560 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg → Period 2 MK-5720 560 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1 → Placebo Period 2
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Period 1
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of MK-5720 in Participants With Schizophrenia (MK-5720-001)
Baseline characteristics by cohort
| Measure |
Panel A: Period 1 MK-8189 4 mg → Period 2 MK-5720 35mg
n=6 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg → Period 2 MK-5720 70 mg
n=7 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1 → Placebo Period 2
n=4 Participants
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.8 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
46.3 Years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
51.5 Years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
47.4 Years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 10 daysPopulation: All participants in Period 1 who received at least one dose of study treatment and had data available for Period 1. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced one or more AEs is reported here for participants in Period 1. Per protocol, this outcome measure has been reported by panel and dose. As specified by the protocol, Period 2 has been analyzed separately and reported later in the record.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=6 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=7 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
n=4 Participants
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experience ≥1 Adverse Event (AE) in Period 1
|
1 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 72 daysPopulation: All participants in Period 2 who received at least one dose of study treatment and had data available for Period 2. In Panel B 1 participant discontinued treatment between Period 1 and Period 2. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced one or more AEs is reported here for participants in Period 2. Per protocol, this outcome measure has been reported by panel and dose. As specified by the protocol, Period 1 has been analyzed separately and reported earlier in the record.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=6 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
n=4 Participants
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experience ≥1 AE(s) in Period 2
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 10 daysPopulation: All participants in Period 1 who received at least one dose of study treatment and had data available for Period 1. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is reported here for participants in Period 1. Per protocol, this outcome measure has been reported by panel and dose. As specified by the protocol, Period 2 has been analyzed separately and reported later in the record.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=6 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=7 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
n=4 Participants
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinue Study Due to an AE in Period 1
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 72 daysPopulation: All participants in Period 2 who received at least one dose of study treatment and had data available for Period 2. In Panel B 1 participant discontinued treatment between Period 1 and Period 2. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study treatment due to an AE is reported here for participants in Period 2. Per protocol, this outcome measure has been reported by panel and dose. As specified by the protocol, Period 1 has been analyzed separately and reported earlier in the record.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=6 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
n=4 Participants
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinue Study Due to an AE in Period 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol population includes all participants who complied with the protocol, had received MK-8189 treatment in Period 1 and MK-5720 treatment in Period 2, and had data available. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
AUC0-last was defined as the area under the concentration-time curve from time zero to time of last measurable concentration of MK-5720. Blood samples were collected at specified intervals were used to estimate AUC0-last following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure has been reported by panel and dose.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=6 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of MK-5720
|
34.3 hr*nM
Geometric Coefficient of Variation 128.3
|
73.3 hr*nM
Geometric Coefficient of Variation 96.2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol population includes all participants who complied with the protocol, had received MK-8189 treatment in Period 1 and MK-5720 treatment in Period 2, and had data available. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
AUC0-inf is defined as the area under concentration-time curve of MK-5720 from time zero to infinity. Blood samples were collected at specified intervals for the determination of AUC-inf following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure has been reported by panel and dose.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=2 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC-inf) of MK-5720
|
70.0 hr*nM
Geometric Coefficient of Variation 61.6
|
134 hr*nM
Geometric Coefficient of Variation 61.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol population includes all participants who complied with the protocol, had received MK-8189 treatment in Period 1 and MK-5720 treatment in Period 2, and had data available. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Cmax is defined as the maximum concentration of MK-5720 reached. Blood samples were collected at specified intervals for the determination of Cmax following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure has been reported by panel and dose.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=6 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of MK-5720
|
0.165 nM
Geometric Coefficient of Variation 156.2
|
0.473 nM
Geometric Coefficient of Variation 105.1
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol population includes all participants who complied with the protocol, had received MK-8189 treatment in Period 1 and MK-5720 treatment in Period 2, and had data available. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Tmax is defined as the time to maximum concentration of MK-5720 reached. Blood samples were collected at specified intervals for the determination of Tmax following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure has been reported by panel and dose.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=6 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of MK-5720
|
48.00 hr
Interval 0.5 to 96.0
|
108.00 hr
Interval 4.0 to 192.12
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol population includes all participants who complied with the protocol, had received MK-8189 treatment in Period 1 and MK-5720 treatment in Period 2, and had data available. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
CL/F is the rate at which the MK-5720 is completely removed from plasma. Blood samples were collected at specified intervals for the determination of CL/F following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure has been reported by panel and dose.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=2 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of MK-5720
|
892 Liters/hr
Geometric Coefficient of Variation 61.6
|
933 Liters/hr
Geometric Coefficient of Variation 61.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol population includes all participants who complied with the protocol, had received MK-8189 treatment in Period 1 and MK-5720 treatment in Period 2, and had data available. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Vz/F is the apparent volume of distribution of MK-5720. Blood samples were collected at specified intervals for the determination of Vz/F following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure has been reported by panel and dose.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=2 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of MK-5720
|
55400 Liters
Geometric Coefficient of Variation 83.2
|
218000 Liters
Geometric Coefficient of Variation 243.8
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol population includes all participants who complied with the protocol, had received MK-8189 treatment in Period 1 and MK-5720 treatment in Period 2, and had data available. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
t1/2 is defined as the time required to divide plasma concentration of MK-5720 by half after reaching pseudo-equilibrium. Blood samples were collected at specified intervals for the determination t1/2 following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure has been reported by panel and dose.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=2 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of MK-5720
|
43.0 hr
Geometric Coefficient of Variation 15.9
|
162 hr
Geometric Coefficient of Variation 271.2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, and 672 hours postdosePopulation: Per protocol population includes all participants who complied with the protocol, had received MK-8189 treatment in Period 1 and MK-5720 treatment in Period 2, and had data available. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
AUC0-28d is defined as the area under the concentration-time curve from time zero to 28 days of MK-8189 (a metabolite of MK-5720). Blood samples were collected at specified intervals for the determination of AUC0-28d for MK-8189 following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure has been reported by panel and dose.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=6 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to 28 Days (AUC0-28d) of MK-8189
|
2850 hr*nM
Geometric Coefficient of Variation 4121.1
|
29800 hr*nM
Geometric Coefficient of Variation 89.3
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol population includes all participants who complied with the protocol, had received MK-8189 treatment in Period 1 and MK-5720 treatment in Period 2, and had data available. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
AUC0-inf is defined as the area under concentration-time curve from time zero to infinity of MK-8189 (a metabolite of MK-5720). Blood samples were collected at specified intervals for the determination of AUC0-inf for MK-8198 following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure has been reported by panel and dose.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=4 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
AUC0-inf of MK-8189
|
8400 hr*nM
Geometric Coefficient of Variation 75.3
|
31900 hr*nM
Geometric Coefficient of Variation 93.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol population includes all participants who complied with the protocol, had received MK-8189 treatment in Period 1 and MK-5720 treatment in Period 2, and had data available. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Cmax is defined as the maximum concentration of MK-8189 (a metabolite of MK-5720) reached. Blood samples were collected at specified intervals for the determination of Cmax for MK-8198 following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure has been reported by panel and dose.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=6 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax of MK-8189
|
18.8 nM
Geometric Coefficient of Variation 569.7
|
104 nM
Geometric Coefficient of Variation 90.1
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol population includes all participants who complied with the protocol, had received MK-8189 treatment in Period 1 and MK-5720 treatment in Period 2, and had data available. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Tmax is defined as the time to maximum concentration of MK-8189 (a metabolite of MK-5720). Blood samples were collected at specified intervals for the determination of Tmax for MK-8198 following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure has been reported by panel and dose.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=6 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Tmax of MK-8189
|
96.00 hr
Interval 24.0 to 504.0
|
120.00 hr
Interval 96.0 to 288.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, and 672 hours postdosePopulation: Per protocol population includes all participants who complied with the protocol, had received MK-8189 treatment in Period 1 and MK-5720 treatment in Period 2, and had data available. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
C28d is defined as the maximum concentration from time zero to 28 days of MK-8189 (a metabolite of MK-5720). Blood samples were collected at specified intervals for the determination of C28d for MK-8198 following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure has been reported by panel and dose. In cases where C28d values were below the limit of quantitation, geometric mean was not calculable and indicated as "NA."
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=6 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Concentration at Day 28 (C28d) of MK-8189
|
NA nM
Geometric Coefficient of Variation NA
NA = Geometric mean (% GCV) were not calculable as plasma concentrations were the below the limit of quantitation.
|
2.96 nM
Geometric Coefficient of Variation 693.7
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol population includes all participants who complied with the protocol, had received MK-8189 treatment in Period 1 and MK-5720 treatment in Period 2, and had data available. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
CL/F is the rate at which the MK-8189 (a metabolite of MK-5720) is completely removed from plasma. Blood samples were collected at specified intervals for the determination of CL/F for MK-8198 following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure has been reported by panel and dose.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=4 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
CL/F of MK-8189
|
7.43 Liters/hr
Geometric Coefficient of Variation 75.3
|
3.92 Liters/hr
Geometric Coefficient of Variation 93.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol population includes all participants who complied with the protocol, had received MK-8189 treatment in Period 1 and MK-5720 treatment in Period 2, and had data available. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Vz/F is the apparent volume of distribution of MK-8189 (a metabolite of MK-5720). Blood samples were collected at specified intervals for the determination of Vz/F for MK-8198 following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure has been reported by panel and dose.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=4 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
Vz/F of MK-8189
|
697 Liters
Geometric Coefficient of Variation 97.0
|
593 Liters
Geometric Coefficient of Variation 126.7
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol population includes all participants who complied with the protocol, had received MK-8189 treatment in Period 1 and MK-5720 treatment in Period 2, and had data available. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
t1/2 is defined as the time required to divide plasma concentration of MK-8189 (a metabolite of MK-5720) by half after reaching pseudo-equilibrium. Blood samples were collected at specified intervals for the determination of Half-life (t1/2) for MK-8198 following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure has been reported by panel and dose.
Outcome measures
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=4 Participants
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=6 Participants
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel C: Period 1 MK-8189 16 mg
Participants received 7 days of oral MK-8189 16 mg (Period 1), followed by a single IM injection of MK-5720 140 mg (Period 2). No participants were enrolled into this arm.
|
Panel D: Period 1 MK-8189 24 mg
Participants received 7 days of oral MK-8189 24 mg (Period 1), followed by a single IM injection of MK-5720 280 mg (Period 2). No participants were enrolled into this arm.
|
Panel E: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2). No participants were enrolled into this arm.
|
Panel F: Period 1 MK-8189 48 mg
Participants received 7 days of oral MK-8189 48 mg (Period 1), followed by a single IM injection of MK-5720 560 mg (Period 2), after a Pharmacokinetic (PK) break following Panel E. No participants were enrolled into this arm.
|
Panels C, D, E, and F: Placebo Period 1
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo (Period 2). No participants were enrolled into this arm.
|
|---|---|---|---|---|---|---|---|---|
|
t1/2 of MK-8189
|
65.0 hr
Geometric Coefficient of Variation 62.5
|
105 hr
Geometric Coefficient of Variation 71.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, and 672 postdosePopulation: Per protocol, this outcome measure is specific for Panels D, E, and F only. Panels C, D, E and F were not enrolled, and no data was collected for this outcome measure. Per protocol, placebo arms were not included in any PK outcome analyses.
C28d tied to specific exposures of MK-8189 is defined as the maximum concentration from time zero to 28 days of MK-8189 tied to specific exposures. Blood samples were collected at specified intervals for the determination of C28d tied to specific exposures of MK-8189 (metabolite of MK-5720) following a single dose administration of MK-5720 in Period 2. Per protocol, this outcome measure is specific for Panels D, E, and F only. Panels C, D, E and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, and 672 hours postdosePopulation: Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A and B. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Blood samples were to be collected at specified intervals for the determination of AUC0-28 of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 (Period 2) in the gluteal muscle and deltoid muscle. AUC0-28 is defined as the area under the plasma concentration-time curve from time zero to 28 days of MK-8189. Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A or B. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A and B. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Blood samples were to be collected at specified intervals for the determination of AUC-inf of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 (Period 2) in the gluteal muscle and deltoid muscle. AUC0-inf is defined as the area under concentration-time curve from time zero to infinity of MK-8189. Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A or B. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A and B. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Blood samples were to be collected at specified intervals for the determination of Cmax of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 (Period 2) in the gluteal muscle and deltoid muscle. Cmax is defined as the maximum concentration of MK-8189. Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A or B. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, 1320 hours postdosePopulation: Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A and B. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Blood samples were to be collected at specified intervals for determination of Tmax of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 (Period 2) in the gluteal muscle and deltoid muscle. Tmax is defined as the time to maximum concentration of MK-8189. Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A or B. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, and 672 hours postdosePopulation: Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A and B. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Blood samples were to be collected at specified intervals for the determination of C28d of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 (Period 2) in the gluteal muscle and deltoid muscle. C28d is defined as the maximum concentration from time zero to 28 days of MK-8189. Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A or B. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A and B. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Blood samples were to be collected at specified intervals for the determination of CL/F of MK-8189 (a metabolite of MK-5720) after administration of MK-5720 (Period 2) in the gluteal muscle and deltoid muscle. CL/F is the rate at which the MK-8189 is completely removed from plasma. Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A or B. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A and B. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Blood samples were to be collected at specified intervals for the determination of distribution of MK-8189 (metabolite of MK-5720) after administration of MK-5720 (Period 2) in the gluteal muscle versus deltoid muscle. Vz/F is the apparent volume of distribution of MK-8189. Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A or B. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A and B. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Blood samples were to be collected at specified intervals for the determination of t1/2 of MK-8189 (metabolite of MK-5720) after administration of MK-5720 (Period 2) in the gluteal muscle and deltoid muscle. t1/2 is defined as the time required divide plasma concentration of MK-8189 (metabolite of MK-5720) by half after reaching pseudo-equilibrium. Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A or B. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A and B. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Blood samples were to be collected at specified intervals for the determination of AUC0-last after administration of MK-5720 (Period 2) in the gluteal muscle and deltoid muscle. AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of MK-5720. Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A or B. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A and B. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Blood samples were to be collected at specified intervals for the determination of AUC-inf after administration of MK-5720 (Period 2) in the gluteal muscle and deltoid muscle. AUC0-inf is defined as the area under concentration-time curve from time zero to infinity. Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A or B. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A and B. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Blood samples were to be collected at specified intervals for the determination of Cmax after administration of MK-5720 (Period 2) in the gluteal muscle and deltoid muscle. Cmax is defined as the maximum concentration of MK-5720 reached. Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A or B. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A and B. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Blood samples were to be collected at specified intervals for the determination of Tmax after administration of MK-5720 (Period 2) in the gluteal muscle and deltoid muscle. Tmax is defined as the time to maximum concentration of MK-5720 reached. Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A or B. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A and B. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Blood samples were to be collected at specified intervals for the determination of CL/F after administration of MK-5720 (Period 2) in the gluteal muscle and deltoid muscle. CL/F is the rate at which the MK-5720 is completely removed from plasma. Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A or B. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A and B. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Blood samples were to be collected at specified intervals for the determination Vz/F after administration of MK-5720 (Period 2) in the gluteal muscle and deltoid muscle. Vz/F is the apparent volume of distribution of MK-5720. Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A or B. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 6, 24, 48, 96, 120, 144, 168, 192, 216, 264, 288, 312, 336, 360, 384, 432, 456, 504, 672, 840, 1008, 1176, and 1320 hours postdosePopulation: Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A and B. Per protocol, placebo arms were not included in any PK outcome analyses. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Blood samples were to be collected at specified intervals for the determination t1/2 after administration of MK-5720 (Period 2) in the gluteal muscle and deltoid muscle. t1/2 is defined as the time required to divide plasma concentration of MK-5720 by half after reaching pseudo-equilibrium. Per protocol, this outcome measure is specific for Panels C, D, E, and F, and data was not planned or collected for Panels A or B. Panels C, D, E, and F were not enrolled, and no data was collected for this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Panel A: Period 1 MK-8189 4 mg
Panel B: Period 1 MK-8189 8 mg
Placebo Period 1
Panel A: Period 2 MK-5720 35mg
Panel B: Period 2 MK-5720 70 mg
Placebo Period 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Panel A: Period 1 MK-8189 4 mg
n=6 participants at risk
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 1 MK-8189 8 mg
n=7 participants at risk
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 1
n=4 participants at risk
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
Panel A: Period 2 MK-5720 35mg
n=6 participants at risk
Participants received 7 days of oral MK-8189 4 mg (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg (Period 2).
|
Panel B: Period 2 MK-5720 70 mg
n=6 participants at risk
Participants received 7 days of oral MK-8189 8 mg (Period 1), followed by a single IM injection of MK-5720 70 mg (Period 2).
|
Placebo Period 2
n=4 participants at risk
Participants received 7 days of oral MK-8189 dose-matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 dose-matched placebo treatment (Period 2).
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
14.3%
1/7 • Number of events 1 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/7 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
16.7%
1/6 • Number of events 1 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
|
General disorders
Pain
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/7 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
16.7%
1/6 • Number of events 1 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/7 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
16.7%
1/6 • Number of events 1 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • Number of events 1 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/7 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
14.3%
1/7 • Number of events 1 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
16.7%
1/6 • Number of events 1 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/7 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
25.0%
1/4 • Number of events 1 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
14.3%
1/7 • Number of events 1 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
14.3%
1/7 • Number of events 1 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/7 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
25.0%
1/4 • Number of events 1 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
14.3%
1/7 • Number of events 1 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/7 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/4 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
0.00%
0/6 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
25.0%
1/4 • Number of events 1 • Up to approximately 82 days
Population for All-cause mortality was All Randomized Participants. Population for non-serious adverse events and serious adverse events consists of all randomized participants who received at least 1 dose of the study intervention and have provided safety data at any time during the study. Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments
- Publication restrictions are in place
Restriction type: OTHER