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

April 8, 2026 updated by: Merck Sharp & Dohme LLC

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 elpipodect in participants with stable bipolar I disorder. There was no hypothesis testing in this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group-Clinical Research ( Site 0009)
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research ( Site 0001)
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Hassman Research Institute Marlton Site ( Site 0006)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Panel C: Placebo
Participants received Panel C MK-8189-matching placebo QD for 14 days.
Drug: Placebo
Oral Tablet
Placebo Comparator: Panel A: Placebo
Participants received Panel A MK-8189-matching placebo QD for 14 days.
Drug: Placebo
Oral Tablet
Placebo Comparator: Panel B: Placebo
Participants received Panel B MK-8189-matching placebo for 14 days.
Drug: Placebo
Oral Tablet
Experimental: Panel A: 24 mg Elpipodect
Participants received 24 mg elpipodect once daily (QD) for 14 days.
Drug: Elpipodect
Oral Tablet
Other Names:
  • MK-8189
Experimental: Panel B: 16 & 24 mg Elpipodect
Participants received 16 mg elpipodect QD on Days 1 to 3 and 24 mg MK-8189 QD on Days 4 to 14.
Drug: Elpipodect
Oral Tablet
Other Names:
  • MK-8189
Experimental: Panel C: 8, 16, & 24 mg Elpipodect
Participants received 8 mg elpipodect Day 1, 16 mg on Day 2 ,and 24 mg on QD Days 3 to 14.
Drug: Elpipodect
Oral Tablet
Other Names:
  • MK-8189

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)
Time Frame: Up to 28 days
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
Time Frame: Up to 14 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2024

Primary Completion (Actual)

August 21, 2024

Study Completion (Actual)

August 21, 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 29, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8189-020
  • MK-8189-020 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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