A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020)

A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-8189 in Participants With Bipolar I Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar I Disorder
• Intervention / Treatment: Drug: Placebo; Drug: MK-8189

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Toll Free Number; Phone Number: 1-888-577-8839; Email: Trialsites@merck.com

Study Locations

• United States
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Recruiting
      • Hassman Research Institute Marlton Site ( Site 0006)
      • Contact: Study Coordinator; Phone Number: 267-981-8911

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

• 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.
• History of receiving and tolerating antipsychotic medication within the usual dose range employed for bipolar I disorder.
• Body mass index is 18 and 40 kg/m^2, inclusive.
• If currently taking an antipsychotic, is able to discontinue it's use at least 5 days prior to study start and the duration of the study.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

• Untreated or uncompensated endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
• Evidence or history of a primary DSM-5 axis I psychiatric diagnosis other than those specified for inclusion.
• History of cancer (malignancy).
• Evidence or history of mental retardation, borderline personality disorder, or organic brain syndrome.
• History of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia.
• Substance-induced psychotic disorder or behavioral disturbance.
• DSM-5 TR defined substance use disorder within 3 months of screening.
• History of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures.
• Positive test(s) for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.
• Major surgery or donation/loss of 1 unit of blood within 4 weeks prior to screening.
• Received any vaccine starting from 30 days prior to study intervention or is scheduled to receive any vaccine through 30 days following study intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panel A: MK-8189 Dosing Regimen 1; Participants will receive MK-8189 once daily (QD) at dosing regimen 1 for up to 14 days.	Drug: MK-8189; Oral Tablet
Experimental: Panel B: MK-8189 Dosing Regimen 2; Participants will receive MK-8189 QD at dosing regimen 2 for up to 14 days.	Drug: MK-8189; Oral Tablet
Experimental: Panel C: MK-8189 Dosing Regimen 3; Participants will receive MK-8189 QD at dosing regimen 3 for up to 14 days.	Drug: MK-8189; Oral Tablet
Placebo Comparator: Placebo; Participants will receive MK-8189-matching placebo QD for up to 14 days.	Drug: Placebo; Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience One or More Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Up to ~28 days
Number of Participants Who Discontinue Study Treatment Due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Up to ~14 days

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): September 10, 2024
• Study Completion (Estimated): September 10, 2024

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 8189-020; MK-8189-020 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No