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New bipolar drug MK-8189 passes early safety check in small study

NCT ID NCT06273774

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

34 people

The number who actually took part.

Started

Apr 2024

Finished

Aug 2024

Lead sponsor

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

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • 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

  • Woodland International Research Group-Clinical Research ( Site 0009)

    Little Rock, Arkansas, 72211, United States

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