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

NCT ID: NCT05953740

Last Updated: 2025-03-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2024-02-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double blind

Study Groups

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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).

Group Type EXPERIMENTAL

MK-5720

Intervention Type DRUG

IM injection

Placebo to MK-5720

Intervention Type DRUG

Placebo IM Injection matched to MK-5720

MK-8189

Intervention Type DRUG

Oral Tablet

Placebo to MK-8189

Intervention Type DRUG

Placebo oral tablet matched to MK-8189

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).

Group Type EXPERIMENTAL

MK-5720

Intervention Type DRUG

IM injection

Placebo to MK-5720

Intervention Type DRUG

Placebo IM Injection matched to MK-5720

MK-8189

Intervention Type DRUG

Oral Tablet

Placebo to MK-8189

Intervention Type DRUG

Placebo oral tablet matched to MK-8189

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).

Group Type EXPERIMENTAL

MK-5720

Intervention Type DRUG

IM injection

Placebo to MK-5720

Intervention Type DRUG

Placebo IM Injection matched to MK-5720

MK-8189

Intervention Type DRUG

Oral Tablet

Placebo to MK-8189

Intervention Type DRUG

Placebo oral tablet matched to MK-8189

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).

Group Type EXPERIMENTAL

MK-5720

Intervention Type DRUG

IM injection

Placebo to MK-5720

Intervention Type DRUG

Placebo IM Injection matched to MK-5720

MK-8189

Intervention Type DRUG

Oral Tablet

Placebo to MK-8189

Intervention Type DRUG

Placebo oral tablet matched to MK-8189

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).

Group Type EXPERIMENTAL

MK-5720

Intervention Type DRUG

IM injection

Placebo to MK-5720

Intervention Type DRUG

Placebo IM Injection matched to MK-5720

MK-8189

Intervention Type DRUG

Oral Tablet

Placebo to MK-8189

Intervention Type DRUG

Placebo oral tablet matched to MK-8189

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.

Group Type EXPERIMENTAL

MK-5720

Intervention Type DRUG

IM injection

Placebo to MK-5720

Intervention Type DRUG

Placebo IM Injection matched to MK-5720

MK-8189

Intervention Type DRUG

Oral Tablet

Placebo to MK-8189

Intervention Type DRUG

Placebo oral tablet matched to MK-8189

Interventions

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MK-5720

IM injection

Intervention Type DRUG

Placebo to MK-5720

Placebo IM Injection matched to MK-5720

Intervention Type DRUG

MK-8189

Oral Tablet

Intervention Type DRUG

Placebo to MK-8189

Placebo oral tablet matched to MK-8189

Intervention Type DRUG

Other Intervention Names

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Normal saline Dextrose

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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California Clinical Trials Medical Group managed by PAREXEL ( Site 0003)

Glendale, California, United States

Site Status

Velocity Clinical Research, Hallandale Beach ( Site 0002)

Hallandale, Florida, United States

Site Status

Research Centers of America ( Hollywood ) ( Site 0001)

Hollywood, Florida, United States

Site Status

Hassman Research Institute Marlton Site ( Site 0007)

Marlton, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MK-5720-001

Identifier Type: OTHER

Identifier Source: secondary_id

5720-001

Identifier Type: -

Identifier Source: org_study_id

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