NCT03565068View on ClinicalTrials.gov

A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007)

PHASE1CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

June 20, 2018

Primary Completion Date

April 3, 2020

Study Completion Date

April 3, 2020

Conditions
Schizophrenia
Interventions
DRUG

MK-8189

MK-8189 4 mg tablet(s) will be administered orally QD for a total daily dose of 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 36 mg or 48 mg.

DRUG

Placebo

MK-8189 dose-matching placebo tablets will be administered orally QD.

DRUG

Background AAP Therapy

Participants with schizophrenia in Panel C will be on background therapy with an AAP medication (e.g., olanzapine, quetiapine, paliperidone, asenapine, iloperidone, aripirprazole, lurasidone, risperidone \[not to exceed daily dose of 6 mg\], or ziprasidone) throughout the study. Participants should be on a stable and well tolerated treatment regimen for at least 2 months prior to screening. NOTE: clozapine is not allowed.

Trial Locations (1)

91206

California Clinical Trials ( Site 0001), Glendale

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03565068 - A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007) | Biotech Hunter | Biotech Hunter