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Completed

NCT Number: NCT05953740

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

California Clinical Trials Medical Group managed by PAREXEL ( Site 0003), Glendale, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-5720

Drug

IM injection

Placebo to MK-5720

Drug

Placebo IM Injection matched to MK-5720

Other names: Normal saline, Dextrose

MK-8189

Drug

Oral Tablet

Placebo to MK-8189

Drug

Placebo oral tablet matched to MK-8189

Primary outcomes

  1. Number of Participants Who Experience ≥1 Adverse Event (AE) in Period 1

    Time frame: Up to approximately 10 days

    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.

  2. Number of Participants Who Experience ≥1 AE(s) in Period 2

    Time frame: Up to approximately 72 days

    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.

  3. Number of Participants Who Discontinue Study Due to an AE in Period 1

    Time frame: Up to approximately 10 days

    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.

  4. Number of Participants Who Discontinue Study Due to an AE in Period 2

    Time frame: Up to approximately 72 days

    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.

  5. Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of MK-5720

    Time frame: 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

    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.

  6. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC-inf) of MK-5720

    Time frame: 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

    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.

  7. Maximum Serum Concentration (Cmax) of MK-5720

    Time frame: 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 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.

  8. Time to Maximum Concentration (Tmax) of MK-5720

    Time frame: 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 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.

  9. Apparent Clearance (CL/F) of MK-5720

    Time frame: 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

    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.

  10. Apparent Volume of Distribution (Vz/F) of MK-5720

    Time frame: 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 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.

  11. Apparent Terminal Half-life (t1/2) of MK-5720

    Time frame: 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 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.

  12. Area Under the Concentration-Time Curve From Time 0 to 28 Days (AUC0-28d) of MK-8189

    Time frame: 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

    AUC0-28d 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.

  13. AUC0-inf of MK-8189

    Time frame: 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

    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.

  14. Cmax of MK-8189

    Time frame: 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 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.

  15. Tmax of MK-8189

    Time frame: 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 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.

  16. Concentration at Day 28 (C28d) of MK-8189

    Time frame: 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

    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."

  17. CL/F of MK-8189

    Time frame: 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

    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.

  18. Vz/F of MK-8189

    Time frame: 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 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.

  19. t1/2 of MK-8189

    Time frame: 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 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.

Secondary outcomes

  1. Panels D, E, and F: C28d Tied to Specific Exposures of MK-8189

    Time frame: 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

    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.

  2. Panels C, D, E, and F: AUC0-28d of MK-8189 in Gluteal Muscle Versus AUC0-28 of MK-8189 in Deltoid Muscle

    Time frame: 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

    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.

  3. Panels C, D, E, and F: AUC0-inf of MK-8189 in Gluteal Muscle Versus AUC0-inf of MK-8189 in Deltoid Muscle

    Time frame: 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

    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.

  4. Panels C, D, E, and F: Cmax of MK-8189 in Gluteal Muscle Versus Cmax of MK-8189 in Deltoid Muscle

    Time frame: 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

    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.

  5. Panels C, D, E, and F: Tmax of MK-8189 in Gluteal Muscle Versus Tmax of MK-8189 in Deltoid Muscle

    Time frame: 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

    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.

  6. Panels C, D, E, and F: C28d of MK-8189 in Gluteal Muscle Versus C28d in Deltoid Muscle

    Time frame: 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

    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.

  7. Panels C, D, E, and F: CL/F of MK-8189 in Gluteal Muscle Versus CL/F in Deltoid Muscle

    Time frame: 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

    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.

  8. Panels C, D, E, and F: Vz/F of MK-8189 in Gluteal Muscle Versus Vz/F of MK-8189 in Deltoid Muscle

    Time frame: 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

    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.

  9. Panels C, D, E, and F: t1/2 of MK-8189 in Gluteal Muscle Versus t1/2 of MK-8189 in Deltoid Muscle

    Time frame: 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

    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.

  10. Panels C, D, E, and F: AUC0-last of MK 5720 in Gluteal Muscle Versus AUC0-last of MK-5720 in Deltoid Muscle

    Time frame: 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

    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.

  11. Panels C, D, E, and F: AUC0-inf of MK-5720 in Gluteal Muscle Versus AUC0-inf of MK-5720 in Deltoid Muscle

    Time frame: 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

    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.

  12. Panels C, D, E, and F: Cmax of MK-5720 in Gluteal Muscle Versus Cmax of MK-5720 in Deltoid Muscle

    Time frame: 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

    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.

  13. Panels C, D, E, and F: Tmax of MK-5720 in Gluteal Muscle Versus Tmax of MK-5720 in Deltoid Muscle

    Time frame: 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

    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.

  14. Panels C, D, E, and F: CL/F of MK-5720 in Gluteal Muscle Versus CL/F of MK-5720 in Deltoid Muscle

    Time frame: 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

    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.

  15. Panels C, D, E, and F: Vz/F of MK-5720 in Gluteal Muscle Versus Vz/F of MK-5720 in Deltoid Muscle

    Time frame: 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

    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.

  16. Panels C, D, E, and F: t1/2 of MK-5720 in Gluteal Muscle Versus t1/2 of MK-5720 in Deltoid Muscle

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 20, 2023
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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