A Study of MK-5720 in Participants With Schizophrenia (MK-5720-001)

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Long-Acting Injectable of MK-5720 in Participants With Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: MK-8189; Drug: MK-5720; Drug: Placebo to MK-5720; Drug: Placebo to MK-8189

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • California Clinical Trials Medical Group managed by PAREXEL ( Site 0003)
  • Florida
    • Hallandale Beach, Florida, United States, 33009
      • Velocity Clinical Research, Hallandale Beach ( Site 0002)
    • Hollywood, Florida, United States, 33024
      • Research Centers of America ( Hollywood ) ( Site 0001)
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Hassman Research Institute Marlton Site ( Site 0007)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

• Meets diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria with the onset of the first episode being no less than 2 years prior to screening and monotherapy with antipsychotics for treatment should be indicated
• Has a history of receiving and tolerating antipsychotics medication within the usual dose range employed for schizophrenia
• Can discontinue the use of all antipsychotic medication at least 5 days or 3 half-lives (which ever in longer) prior to the start of the treatment period and during the study

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

• Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator
• Has history of mental retardation, borderline personality disorder, or organic brain syndrome
• Has a history of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia
• Has a substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse
• Has a history of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures
• Has a family history of sudden death
• Has claustrophobia to a degree that prevents tolerance of magnetic resonance imaging (MRI) scanning procedure
• Has a metallic implant of any sort that prevents MRI examination, or any other contraindication to MRI examination
• Presents any concern by the investigator regarding safe participation in the study or for any other reason the investigator considers the participant inappropriate for participation in the study
• History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
• Positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
• Has received or is currently receiving treatment with clozapine for any length of time
• Has received any live vaccines within 30 days prior to the first dose of study intervention or is scheduled to receive any live vaccine through 60 days following study intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panel A; 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).	Drug: MK-8189; Oral Tablet; Drug: MK-5720; IM injection; Drug: Placebo to MK-5720; Placebo IM Injection matched to MK-5720; Other Names: Normal saline; Dextrose; Drug: Placebo to MK-8189; Placebo oral tablet matched to MK-8189
Experimental: Panel B; 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).	Drug: MK-8189; Oral Tablet; Drug: MK-5720; IM injection; Drug: Placebo to MK-5720; Placebo IM Injection matched to MK-5720; Other Names: Normal saline; Dextrose; Drug: Placebo to MK-8189; Placebo oral tablet matched to MK-8189
Experimental: Panel C; 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).	Drug: MK-8189; Oral Tablet; Drug: MK-5720; IM injection; Drug: Placebo to MK-5720; Placebo IM Injection matched to MK-5720; Other Names: Normal saline; Dextrose; Drug: Placebo to MK-8189; Placebo oral tablet matched to MK-8189
Experimental: Panel D; 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).	Drug: MK-8189; Oral Tablet; Drug: MK-5720; IM injection; Drug: Placebo to MK-5720; Placebo IM Injection matched to MK-5720; Other Names: Normal saline; Dextrose; Drug: Placebo to MK-8189; Placebo oral tablet matched to MK-8189
Experimental: Panel E; 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).	Drug: MK-8189; Oral Tablet; Drug: MK-5720; IM injection; Drug: Placebo to MK-5720; Placebo IM Injection matched to MK-5720; Other Names: Normal saline; Dextrose; Drug: Placebo to MK-8189; Placebo oral tablet matched to MK-8189
Experimental: Panel F; 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.	Drug: MK-8189; Oral Tablet; Drug: MK-5720; IM injection; Drug: Placebo to MK-5720; Placebo IM Injection matched to MK-5720; Other Names: Normal saline; Dextrose; Drug: Placebo to MK-8189; Placebo oral tablet matched to MK-8189

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: 5720-001; MK-5720-001 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No