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NCT06273774CompletedPhase 1

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

Source: ClinicalTrials.gov · Last updated 29 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
34 (actual)
First submitted
15 Feb 2024
Start date
8 Apr 2024
Primary completion date
21 Aug 2024
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT06273774

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 34
  • From 8 Apr 2024 to the primary completion date, 21 Aug 2024
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures.
  • 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.

Other illness

  • 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.
  • Positive test(s) for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.

Other

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

Who the study is looking for

  • 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.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Atlanta Center for Medical Research ( Site 0001)
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Woodland International Research Group-Clinical Research ( Site 0009)
Coordinator of this site? Confirm its status
Little RockUnited StatesUnknown status
Hassman Research Institute Marlton Site ( Site 0006)
Coordinator of this site? Confirm its status
MarltonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.