New bipolar drug MK-8189 passes early safety check in small study
NCT ID NCT06273774
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested the safety of a drug called MK-8189 in 34 adults with stable bipolar I disorder. Researchers monitored side effects and how the drug moved through the body. The goal was to see if the drug is safe enough for further testing, not to measure how well it works.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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34 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Aug 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Atlanta Center for Medical Research ( Site 0001)
Atlanta, Georgia, 30331, United States
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Hassman Research Institute Marlton Site ( Site 0006)
Marlton, New Jersey, 08053, United States
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Woodland International Research Group-Clinical Research ( Site 0009)
Little Rock, Arkansas, 72211, United States
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Other studies related to the condition(s) this trial covers.
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