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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2024-08-21

Brief Summary

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The goal of this study is to evaluate the safety and tolerability of MK-8189 in participants with stable bipolar I disorder. There was no hypothesis testing in this study.

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Detailed Description

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Conditions

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Bipolar I Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Panel A: 24 mg MK-8189

Participants received 24 mg MK-8189 once daily (QD) for 14 days.

Group Type EXPERIMENTAL

MK-8189

Intervention Type DRUG

Oral Tablet

Panel B: 16 & 24 mg MK-8189

Participants received 16 mg MK-8189 QD on Days 1 to 3 and 24 mg MK-8189 QD on Days 4 to 14.

Group Type EXPERIMENTAL

MK-8189

Intervention Type DRUG

Oral Tablet

Panel C: 8, 16, & 24 mg MK-8189

Participants received 8 mg MK-8189 Day 1, 16 mg on Day 2 ,and 24 mg on QD Days 3 to 14.

Group Type EXPERIMENTAL

MK-8189

Intervention Type DRUG

Oral Tablet

Panel C: Placebo

Participants received Panel C MK-8189-matching placebo QD for 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral Tablet

Panel A: Placebo

Participants received Panel A MK-8189-matching placebo QD for 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral Tablet

Panel B: Placebo

Participants received Panel B MK-8189-matching placebo for 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral Tablet

Interventions

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MK-8189

Oral Tablet

Intervention Type DRUG

Placebo

Oral Tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No