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Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and Healthy Participants (MK-8189-011) | Clinical Trials | Clareo Health

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Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and Healthy Participants (MK-8189-011)

A 2-Part Randomized Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Alternate MK-8189 Titration Regimens in Young Adult Participants With Schizophrenia and to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-8189 in Elderly Participants With Schizophrenia and Healthy Elderly

NCT04506905•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, 2-part clinical study of the safety, tolerability and pharmacokinetics of alternate MK-8189 titration regimens. Part 1 assessed multiple dose once-daily titration regimens of MK-8189 in young adult participants with schizophrenia. Part 2 assessed multiple once-daily doses of MK-8189 in elderly participants with schizophrenia and healthy elderly participants.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Has a body mass index (BMI) ≤40 kg/m2
•Has no clinically significant abnormality on 12-lead safety electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to randomization
•Has a normal resting blood pressure (BP: systolic BP is ≥90 millimeter of mercury \[mmHg\] and ≤140 mmHg; diastolic BP is ≥60 mmHg and ≤90 mmHg) and normal resting heart rate (≥45 beats per minute \[bpm\] and ≤100 bpm) in the semirecumbent position at the prestudy (screening) visit and/or prior to randomization. Repeat evaluations may be done if the values for a participant are, per investigator discretion, minimally outside the designated range. Participants may be included if values are outside the normal range but considered not clinically significant per investigator discretion
•Participants with schizophrenia only: 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
•Participants with schizophrenia only: Has a total Brief Psychiatric Rating Scale (BPRS) score of \<48 with a BPRS score \<4 for #10 (hostility) and #14 (uncooperativeness) at the screening visit
•Participants with schizophrenia only: Is in the nonacute phase of their illness and clinically stable for 3 months prior to screening as demonstrated by the following: 1) no clinically significant change in dose of prescribed antipsychotic medication, or clinically significant change in antipsychotic medication to treat symptoms of schizophrenia for 2 months prior to screening 2) no increase in level of psychiatric care due to worsening of symptoms of schizophrenia for 3 months prior to screening
•Participants with schizophrenia only: Has a history of receiving and tolerating antipsychotic medication within the usual dose range employed for schizophrenia
•Participants with schizophrenia only: Has a stable living situation
•Participants with hypothyroidism, diabetes, high BP, chronic respiratory conditions or other mild forms of these medical conditions could be considered as candidates for study enrollment if their condition is stable
•Has regular bowel movements
+2 more criteria

Exclusion Criteria

•Is a WOCBP who has a positive urine pregnancy test within 48 hours before the first dose of study intervention
•Participants with schizophrenia only: Has evidence or history of a primary DSM-5 axis I psychiatric diagnosis other than schizophrenia or schizoaffective disorder per the allowed DSM-5 criteria within 1 month of screening
•Has evidence or history of a primary DSM-5 axis I psychiatric diagnosis other than schizophrenia or schizoaffective disorder per the allowed DSM-5 criteria within 1 month of screening
•Has evidence or history of mental retardation, borderline personality disorder, anxiety 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 DSM-5 defined substance use disorder within 3 months of screening
•Has a history of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures
•Has an untreated or uncompensated clinically significant renal, endocrine, hepatic, respiratory, gastrointestinal, psychiatric, neurologic, cardiovascular, hematological, immunological or cerebrovascular disease, malignancy, allergic disease or other chronic and/or degenerative process at screening
•Has any clinically significant abnormal laboratory, vital sign (VS), physical examination, or 12-lead safety ECG findings at screening or changes from baseline parameters or, in the opinion of the investigator, would make the participant inappropriate for entry into this study
+23 more criteria

Locations (6)

Woodland Research Northwest, LLC ( Site 0002)

Rogers, Arkansas, United States

Parexel ( Site 0004)

Glendale, California, United States

Collaborative NeuroScience Network ( Site 0008)

Long Beach, California, United States

Velocity Clinical Research, Hallandale Beach ( Site 0001)

Hallandale, Florida, United States

RCA at Fort Lauderdale Behavioral Health Center ( Site 0006)

Oakland Park, Florida, United States

Hassman Research Institute ( Site 0007)

Berlin, New Jersey, United States

Key Dates

Start Date

August 28, 2020

Primary Completion Date

March 22, 2022

Completion Date

March 22, 2022

Last Updated

October 2, 2024

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

MK-8189

DRUG

Placebo

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and Healthy Participants (MK-8189-011)

Inclusion Criteria

Exclusion Criteria

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