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

Bipolar I Disorder Clinical Trial

Official title:

A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-8189 in Participants With Bipolar I Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273774
• Other study ID #: 8189-020
• Secondary ID: MK-8189-020
• Status: Recruiting
• Phase: Phase 1
• Start date: April 8, 2024
• Est. completion date: September 10, 2024

Study information

• Verified date: May 2024
• Source: Merck Sharp & Dohme LLC
• Contact: Toll Free Number
• Phone: 1-888-577-8839
• Email: Trialsites[@]merck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: September 10, 2024
• Est. primary completion date: September 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 it's 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.

Related Conditions & MeSH terms

• Bipolar I Disorder

Intervention

Drug:
• MK-8189
Oral Tablet
• Placebo
Oral Tablet

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research ( Site 0001)	Atlanta	Georgia
United States	Woodland International Research Group-Clinical Research ( Site 0009)	Little Rock	Arkansas
United States	Hassman Research Institute Marlton Site ( Site 0006)	Marlton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Merck Clinical Trials Information