MK-8189 for Bipolar Disorder

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Merck Sharp & Dohme LLC

Trial Summary

What is the purpose of this trial?

The goal of this study is to evaluate the safety and tolerability of MK-8189 in participants with stable bipolar I disorder. There will be no hypothesis testing in this study.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with a stable form of bipolar I disorder, who have previously tolerated antipsychotic medication. Participants must have a body mass index between 18 and 40 kg/m^2 and can discontinue current antipsychotics at least 5 days before the study starts.

Inclusion Criteria

I can stop taking antipsychotic medication 5 days before and during the study.

Meets diagnostic criteria for bipolar I disorder, manic or mixed features according to the Diagnostic and Statistical Manual of Mental Disorders TR (DSM-5 TR) and considered to be in a non-acute phase of their illness

Body mass index is between 18 and 40 kg/m^2, inclusive

Exclusion Criteria

I do not have untreated major health issues affecting my body's systems.

Evidence or history of a primary DSM-5 axis I psychiatric diagnosis other than those specified for inclusion

I have had cancer before.

Treatment Details

Interventions

• MK-8189 (Other)

Trial Overview The study is testing MK-8189, a potential treatment for bipolar I disorder. It will compare the effects of MK-8189 against a placebo (a substance with no active drug) to assess its safety and tolerability in participants.

Participant Groups

Group I: Panel C: MK-8189 Dosing Regimen 3 Experimental Treatment 1 Intervention

Participants will receive MK-8189 QD at dosing regimen 3 for up to 14 days.

Group II: Panel B: MK-8189 Dosing Regimen 2 Experimental Treatment 1 Intervention

Participants will receive MK-8189 QD at dosing regimen 2 for up to 14 days.

Group III: Panel A: MK-8189 Dosing Regimen 1 Experimental Treatment 1 Intervention

Participants will receive MK-8189 once daily (QD) at dosing regimen 1 for up to 14 days.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive MK-8189-matching placebo QD for up to 14 days.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University