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

Phase 1

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1, 4, 7, 10, and 13: predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose

Summary

This trial tests a new medication called MK-8189 to see if it's safe and how it behaves in the body. It involves young adults with schizophrenia and elderly participants, both with and without schizophrenia.

Eligible Conditions

Schizophrenia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 4, 7, 10, and 13: predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 4, 7, 10, and 13: predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 4, 7, 10, and 13: predose and 2, 6, 8, 10, 12, 16, and 24 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1 & 2: Number of Participants Discontinuing Study Treatment Due to an AE

Part 1 & 2: Number of Participants Who Experienced an Adverse Event (AE)

Secondary study objectives

Part 1: Apparent Terminal Half-life (t½) of MK-8189

Part 1: Area Under the Concentration Time-curve From Hour 0 to 24 Hours Postdose (AUC0-24) of MK-8189

Part 1: Clearance (CL/F) of MK-8189

+11 more

Side effects data

From 2018 Phase 2 trial • 224 Patients • NCT03055338

18%

Weight increased

13%

Sedation

11%

Headache

Dizziness

Akathisia

Nausea

Fatigue

Dyspepsia

Lethargy

Agitation

Schizophrenia

Somnolence

Decreased appetite

Vomiting

Anxiety

Alcohol poisoning

100%

80%

60%

40%

20%

Study treatment Arm

Risperidone

MK-8189

Placebo

Trial Design

9Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2 (Panel G) MK-8189Experimental Treatment1 Intervention

Healthy elderly adult participants receive MK-8189 titrated from 16 mg to 24 mg QD, orally, over the course of 10-day treatment period with starting doses based on safety and tolerability of previous starting dose in previous panels.

Group II: Part 2 (Panel F) MK-8189Experimental Treatment1 Intervention

Healthy elderly adult participants receive MK-8189 titrated from 8 mg to 24 mg QD, orally, over the course of a 13-day treatment period with starting doses based on safety and tolerability of previous starting dose in previous panels.

Group III: Part 2 (Panel E) MK-8189Experimental Treatment1 Intervention

Elderly adult participants with schizophrenia receive MK-8189 titrated from 16 mg to 24 mg QD, orally, over the course of 10-day treatment period with starting doses based on safety and tolerability of previous starting dose in previous panels.

Group IV: Part 2 (Panel D) MK-8189Experimental Treatment1 Intervention

Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg to 24 mg QD, orally, over the course of a 13-day treatment period with starting doses based on safety and tolerability of previous starting dose in previous panels.

Group V: Part 1 (Panel C) MK-8189Experimental Treatment1 Intervention

Young adult participants with schizophrenia receive MK-8189 titrated from 8 mg to 24 mg QD, orally, over a course of 7-day treatment period with starting doses based on safety and tolerability of previous starting dose in previous panels.

Group VI: Part 1 (Panel B) MK-8189Experimental Treatment1 Intervention

Young adult participants with schizophrenia receive MK-8189 titrated up to 24 mg QD, orally, over a course of 7-day treatment period with starting doses based on safety and tolerability of previous starting dose in previous panel.

Group VII: Part 1 (Panel A) MK-8189Experimental Treatment1 Intervention

Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg to 24 mg once daily (QD), orally, over a course of 7-day treatment.

Group VIII: Part 2 (Panels D, E, F, G) PlaceboPlacebo Group1 Intervention

Oral tablets of dose-matched placebo to total daily dose of MK-8189.

Group IX: Part 1 (Panels A, B, C) PlaceboPlacebo Group1 Intervention

Oral tablets of dose-matched placebo to total daily dose of MK-8189.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-8189

2020