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| ID | Type | Description | Link |
|---|---|---|---|
| MK-5720-001 | Other Identifier | MSD |
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The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending intramuscular doses of MK-5720, and the safety and tolerability of multiple once-daily oral doses of MK-8189, in participants with schizophrenia. The primary study hypothesis is that the administration of MK-5720 is safe and well tolerated.
In Period 1, participants receive once-daily MK-8189 for 7 days, followed by a 72-hour washout. In Period 2, participants receive a single dose of MK-5720.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A | Experimental | Participants received 7 days of oral MK-8189 4 mg or matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg or a dose matched placebo (Period 2). |
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| Panel B | Experimental | Participants received 7 days of oral MK-8189 8 mg or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 70 mg or a dose matched placebo (Period 2). |
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| Panel C | Experimental | Participants received 7 days of oral MK-8189 up to 16 mg or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 up to 140 mg or a dose matched placebo (Period 2). |
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| Panel D | Experimental | Participants received 7 days of oral MK-8189 up to 24 mg or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 up to 280 mg or a dose matched placebo (Period 2). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-5720 | Drug | IM injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience ≥1 Adverse Event (AE) in Period 1 | 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. | Up to approximately 10 days |
| Number of Participants Who Experience ≥1 AE(s) in Period 2 | 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. | Up to approximately 72 days |
| Number of Participants Who Discontinue Study Due to an AE in Period 1 | 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. | Up to approximately 10 days |
| Number of Participants Who Discontinue Study Due to an AE in Period 2 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Panels D, E, and F: C28d Tied to Specific Exposures of MK-8189 | 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. |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group managed by PAREXEL ( Site 0003) | Glendale | California | 91206 | United States | ||
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| FG002 | 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). |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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Panels C, D, E, and F were not enrolled, and no data was collected for these panels.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Panel B: Period 1 MK-8189 8 mg → Period 2 MK-5720 70 mg |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experience ≥1 Adverse Event (AE) in Period 1 | 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. | 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. | Posted | Count of Participants | Participants | Up to approximately 10 days |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Panel A: Period 1 MK-8189 4 mg | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2023 | Jan 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D005947 | Glucose |
| C000729358 | MK-8189 |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Double blind
| Panel E | Experimental | Participants received 7 days of oral MK-8189 up to 48 mg or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 up to 560 mg or a dose matched placebo (Period 2). |
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| Panel F | Experimental | Participants received 7 days of oral MK-8189 up to 48 mg or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 up to 560 mg or a dose matched placebo (Period 2), after a Pharmacokinetic (PK) break following Panel E. |
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| Placebo to MK-5720 | Drug | Placebo IM Injection matched to MK-5720 |
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| MK-8189 | Drug | Oral Tablet |
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| Placebo to MK-8189 | Drug | Placebo oral tablet matched to MK-8189 |
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| Up to approximately 72 days |
| Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of MK-5720 | 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. | 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 postdose |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC-inf) of MK-5720 | 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. | 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 postdose |
| Maximum Serum Concentration (Cmax) of MK-5720 | 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. | 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 postdose |
| Time to Maximum Concentration (Tmax) of MK-5720 | 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. | 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 postdose |
| Apparent Clearance (CL/F) of MK-5720 | 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. | 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 postdose |
| Apparent Volume of Distribution (Vz/F) of MK-5720 | 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. | 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 postdose |
| Apparent Terminal Half-life (t1/2) of MK-5720 | 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. | 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 postdose |
| Area Under the Concentration-Time Curve From Time 0 to 28 Days (AUC0-28d) of MK-8189 | 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. | 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 postdose |
| AUC0-inf of MK-8189 | 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. | 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 postdose |
| Cmax of MK-8189 | 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. | 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 postdose |
| Tmax of MK-8189 | 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. | 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 postdose |
| Concentration at Day 28 (C28d) of MK-8189 | 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." | 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 postdose |
| CL/F of MK-8189 | 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. | 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 postdose |
| Vz/F of MK-8189 | 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. | 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 postdose |
| t1/2 of MK-8189 | 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. | 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 postdose |
| 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 postdose |
| Panels C, D, E, and F: AUC0-28d of MK-8189 in Gluteal Muscle Versus AUC0-28 of MK-8189 in Deltoid Muscle | 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. | 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 postdose |
| Panels C, D, E, and F: AUC0-inf of MK-8189 in Gluteal Muscle Versus AUC0-inf of MK-8189 in Deltoid Muscle | 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. | 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 postdose |
| Panels C, D, E, and F: Cmax of MK-8189 in Gluteal Muscle Versus Cmax of MK-8189 in Deltoid Muscle | 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. | 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 postdose |
| Panels C, D, E, and F: Tmax of MK-8189 in Gluteal Muscle Versus Tmax of MK-8189 in Deltoid Muscle | 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. | 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 postdose |
| Panels C, D, E, and F: C28d of MK-8189 in Gluteal Muscle Versus C28d in Deltoid Muscle | 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. | 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 postdose |
| Panels C, D, E, and F: CL/F of MK-8189 in Gluteal Muscle Versus CL/F in Deltoid Muscle | 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. | 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 postdose |
| Panels C, D, E, and F: Vz/F of MK-8189 in Gluteal Muscle Versus Vz/F of MK-8189 in Deltoid Muscle | 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. | 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 postdose |
| Panels C, D, E, and F: t1/2 of MK-8189 in Gluteal Muscle Versus t1/2 of MK-8189 in Deltoid Muscle | 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. | 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 postdose |
| Panels C, D, E, and F: AUC0-last of MK 5720 in Gluteal Muscle Versus AUC0-last of MK-5720 in Deltoid Muscle | 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. | 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 postdose |
| Panels C, D, E, and F: AUC0-inf of MK-5720 in Gluteal Muscle Versus AUC0-inf of MK-5720 in Deltoid Muscle | 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. | 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 postdose |
| Panels C, D, E, and F: Cmax of MK-5720 in Gluteal Muscle Versus Cmax of MK-5720 in Deltoid Muscle | 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. | 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 postdose |
| Panels C, D, E, and F: Tmax of MK-5720 in Gluteal Muscle Versus Tmax of MK-5720 in Deltoid Muscle | 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. | 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 postdose |
| Panels C, D, E, and F: CL/F of MK-5720 in Gluteal Muscle Versus CL/F of MK-5720 in Deltoid Muscle | 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. | 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 postdose |
| Panels C, D, E, and F: Vz/F of MK-5720 in Gluteal Muscle Versus Vz/F of MK-5720 in Deltoid Muscle | 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. | 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 postdose |
| Panels C, D, E, and F: t1/2 of MK-5720 in Gluteal Muscle Versus t1/2 of MK-5720 in Deltoid Muscle | 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. | 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 postdose |
| Velocity Clinical Research, Hallandale Beach ( Site 0002) |
| Hallandale |
| Florida |
| 33009 |
| United States |
| Research Centers of America ( Hollywood ) ( Site 0001) | Hollywood | Florida | 33024 | United States |
| Hassman Research Institute Marlton Site ( Site 0007) | Marlton | New Jersey | 08053 | United States |
| COMPLETED |
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| NOT COMPLETED |
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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). |
| BG002 | 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). |
| BG003 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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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).
| OG001 | Panel B: Period 1 MK-8189 8 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). |
| OG002 | 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). |
| OG003 | 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. |
| OG004 | 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. |
| OG005 | 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. |
| OG006 | 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. |
| OG007 | 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. |
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| Primary | Number of Participants Who Experience ≥1 AE(s) in Period 2 | 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. | 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. | Posted | Count of Participants | Participants | Up to approximately 72 days |
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| Primary | Number of Participants Who Discontinue Study Due to an AE in Period 1 | 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. | 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. | Posted | Count of Participants | Participants | Up to approximately 10 days |
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| Primary | Number of Participants Who Discontinue Study Due to an AE in Period 2 | 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. | 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. | Posted | Count of Participants | Participants | Up to approximately 72 days |
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| Primary | Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of MK-5720 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*nM | 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 postdose |
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| Primary | Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC-inf) of MK-5720 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*nM | 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 postdose |
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| Primary | Maximum Serum Concentration (Cmax) of MK-5720 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nM | 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 postdose |
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| Primary | Time to Maximum Concentration (Tmax) of MK-5720 | 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. | 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. | Posted | Median | Full Range | hr | 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 postdose |
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| Primary | Apparent Clearance (CL/F) of MK-5720 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/hr | 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 postdose |
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| Primary | Apparent Volume of Distribution (Vz/F) of MK-5720 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | 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 postdose |
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| Primary | Apparent Terminal Half-life (t1/2) of MK-5720 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | 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 postdose |
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| Primary | Area Under the Concentration-Time Curve From Time 0 to 28 Days (AUC0-28d) of MK-8189 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*nM | 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 postdose |
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| Primary | AUC0-inf of MK-8189 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*nM | 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 postdose |
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| Primary | Cmax of MK-8189 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nM | 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 postdose |
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| Primary | Tmax of MK-8189 | 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. | 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. | Posted | Median | Full Range | hr | 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 postdose |
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| Primary | Concentration at Day 28 (C28d) of MK-8189 | 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." | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nM | 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 postdose |
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| Primary | CL/F of MK-8189 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/hr | 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 postdose |
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| Primary | Vz/F of MK-8189 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | 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 postdose |
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| Primary | t1/2 of MK-8189 | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | 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 postdose |
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| Secondary | Panels D, E, and F: C28d Tied to Specific Exposures of MK-8189 | 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. | 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. | Posted | 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 postdose |
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| Secondary | Panels C, D, E, and F: AUC0-28d of MK-8189 in Gluteal Muscle Versus AUC0-28 of MK-8189 in Deltoid Muscle | 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. | 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. | Posted | 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 postdose |
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| Secondary | Panels C, D, E, and F: AUC0-inf of MK-8189 in Gluteal Muscle Versus AUC0-inf of MK-8189 in Deltoid Muscle | 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. | 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. | Posted | 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 postdose |
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| Secondary | Panels C, D, E, and F: Cmax of MK-8189 in Gluteal Muscle Versus Cmax of MK-8189 in Deltoid Muscle | 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. | 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. | Posted | 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 postdose |
|
|
| Secondary | Panels C, D, E, and F: Tmax of MK-8189 in Gluteal Muscle Versus Tmax of MK-8189 in Deltoid Muscle | 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. | 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. | Posted | 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 postdose |
|
|
| Secondary | Panels C, D, E, and F: C28d of MK-8189 in Gluteal Muscle Versus C28d in Deltoid Muscle | 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. | 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. | Posted | 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 postdose |
|
|
| Secondary | Panels C, D, E, and F: CL/F of MK-8189 in Gluteal Muscle Versus CL/F in Deltoid Muscle | 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. | 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. | Posted | 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 postdose |
|
|
| Secondary | Panels C, D, E, and F: Vz/F of MK-8189 in Gluteal Muscle Versus Vz/F of MK-8189 in Deltoid Muscle | 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. | 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. | Posted | 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 postdose |
|
|
| Secondary | Panels C, D, E, and F: t1/2 of MK-8189 in Gluteal Muscle Versus t1/2 of MK-8189 in Deltoid Muscle | 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. | 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. | Posted | 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 postdose |
|
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| Secondary | Panels C, D, E, and F: AUC0-last of MK 5720 in Gluteal Muscle Versus AUC0-last of MK-5720 in Deltoid Muscle | 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. | 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. | Posted | 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 postdose |
|
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| Secondary | Panels C, D, E, and F: AUC0-inf of MK-5720 in Gluteal Muscle Versus AUC0-inf of MK-5720 in Deltoid Muscle | 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. | 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. | Posted | 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 postdose |
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|
| Secondary | Panels C, D, E, and F: Cmax of MK-5720 in Gluteal Muscle Versus Cmax of MK-5720 in Deltoid Muscle | 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. | 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. | Posted | 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 postdose |
|
|
| Secondary | Panels C, D, E, and F: Tmax of MK-5720 in Gluteal Muscle Versus Tmax of MK-5720 in Deltoid Muscle | 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. | 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. | Posted | 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 postdose |
|
|
| Secondary | Panels C, D, E, and F: CL/F of MK-5720 in Gluteal Muscle Versus CL/F of MK-5720 in Deltoid Muscle | 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. | 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. | Posted | 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 postdose |
|
|
| Secondary | Panels C, D, E, and F: Vz/F of MK-5720 in Gluteal Muscle Versus Vz/F of MK-5720 in Deltoid Muscle | 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. | 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. | Posted | 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 postdose |
|
|
| Secondary | Panels C, D, E, and F: t1/2 of MK-5720 in Gluteal Muscle Versus t1/2 of MK-5720 in Deltoid Muscle | 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. | 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. | Posted | 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 postdose |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Panel B: Period 1 MK-8189 8 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). | 0 | 7 | 0 | 7 | 4 | 7 |
| EG002 | 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). | 0 | 4 | 0 | 4 | 2 | 4 |
| EG003 | Panel A: 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). | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | Panel B: 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). | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | 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). | 0 | 4 | 0 | 4 | 1 | 4 |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
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
| D006601 |
| Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |