A Study of Elpipodect (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
2 other identifiers
interventional
34
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2024
Shorter than P25 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2024
CompletedFirst Posted
Study publicly available on registry
February 23, 2024
CompletedStudy Start
First participant enrolled
April 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2024
CompletedResults Posted
Study results publicly available
August 17, 2025
CompletedApril 29, 2026
April 1, 2026
5 months
February 15, 2024
July 2, 2025
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (6)
Panel A: 24 mg Elpipodect
EXPERIMENTALParticipants received 24 mg elpipodect once daily (QD) for 14 days.
Panel B: 16 & 24 mg Elpipodect
EXPERIMENTALParticipants received 16 mg elpipodect QD on Days 1 to 3 and 24 mg MK-8189 QD on Days 4 to 14.
Panel C: 8, 16, & 24 mg Elpipodect
EXPERIMENTALParticipants received 8 mg elpipodect Day 1, 16 mg on Day 2 ,and 24 mg on QD Days 3 to 14.
Panel C: Placebo
PLACEBO COMPARATORParticipants received Panel C MK-8189-matching placebo QD for 14 days.
Panel A: Placebo
PLACEBO COMPARATORParticipants received Panel A MK-8189-matching placebo QD for 14 days.
Panel B: Placebo
PLACEBO COMPARATORParticipants received Panel B MK-8189-matching placebo for 14 days.
Interventions
Oral Tablet
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Untreated or uncompensated endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Woodland International Research Group-Clinical Research ( Site 0009)
Little Rock, Arkansas, 72211, United States
Atlanta Center for Medical Research ( Site 0001)
Atlanta, Georgia, 30331, United States
Hassman Research Institute Marlton Site ( Site 0006)
Marlton, New Jersey, 08053, United States
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme LLC
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2024
First Posted
February 23, 2024
Study Start
April 8, 2024
Primary Completion
August 21, 2024
Study Completion
August 21, 2024
Last Updated
April 29, 2026
Results First Posted
August 17, 2025
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf