Bipolar I DisorderPhase 1NCT06273774

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

A Phase 1 study testing Elpipodect in people with Bipolar I Disorder, run by Merck Sharp & Dohme LLC at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Bipolar I Disorder
What is being tested?: Elpipodect
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 3 sitesUnited States
Study dates: 8 Apr 2024to 21 Aug 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Atlanta Center for Medical Research ( Site 0001)
Atlanta, Georgia, 30331
Woodland International Research Group-Clinical Research ( Site 0009)
Little Rock, Arkansas, 72211
Hassman Research Institute Marlton Site ( Site 0006)
Marlton, New Jersey, 08053

Other trials in United States

About this study

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

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.

Conditions: Bipolar I Disorder
Being tested: Elpipodect, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ElpipodectDrug
Also called MK-8189
Oral Tablet
PlaceboDrug
Oral Tablet

Study groups in NCT06273774
Study group	Role	What they receive
Panel A: 24 mg Elpipodect	Experimental	Participants received 24 mg elpipodect once daily (QD) for 14 days. Receives: Drug: Elpipodect
Panel B: 16 & 24 mg Elpipodect	Experimental	Participants received 16 mg elpipodect QD on Days 1 to 3 and 24 mg MK-8189 QD on Days 4 to 14. Receives: Drug: Elpipodect
Panel C: 8, 16, & 24 mg Elpipodect	Experimental	Participants received 8 mg elpipodect Day 1, 16 mg on Day 2 ,and 24 mg on QD Days 3 to 14. Receives: Drug: Elpipodect
Panel C: Placebo	Placebo comparator	Participants received Panel C MK-8189-matching placebo QD for 14 days. Receives: Drug: Placebo
Panel A: Placebo	Placebo comparator	Participants received Panel A MK-8189-matching placebo QD for 14 days. Receives: Drug: Placebo
Panel B: Placebo	Placebo comparator	Participants received Panel B MK-8189-matching placebo for 14 days. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 28 days
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.
Measured: Up to 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 202421 Aug 2024

First posted23 Feb 2024
Study start8 Apr 2024
Primary completion21 Aug 2024
Study completion21 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06273774
Sponsor's protocol ID: 8189-020
Other IDs: MK-8189-020
Status last verified: Apr 2026
First submitted: 15 Feb 2024
Last updated: 29 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bipolar I Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-8189 in Participants With Bipolar I Disorder
ClinicalTrials.gov ID: NCT06273774
Acronym / sponsor ID: 8189-020
Conditions: Bipolar I Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 8 Apr 2024 (actual)
Primary completion: 21 Aug 2024 (actual)
Study completion: 21 Aug 2024 (actual)
First posted: 23 Feb 2024 (actual)
Results: Posted 17 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Panel A: 24 mg Elpipodect	Experimental	Drug: ElpipodectParticipants received 24 mg elpipodect once daily (QD) for 14 days.
Panel B: 16 & 24 mg Elpipodect	Experimental	Drug: ElpipodectParticipants received 16 mg elpipodect QD on Days 1 to 3 and 24 mg MK-8189 QD on Days 4 to 14.
Panel C: 8, 16, & 24 mg Elpipodect	Experimental	Drug: ElpipodectParticipants received 8 mg elpipodect Day 1, 16 mg on Day 2 ,and 24 mg on QD Days 3 to 14.
Panel C: Placebo	Placebo comparator	Drug: PlaceboParticipants received Panel C MK-8189-matching placebo QD for 14 days.
Panel A: Placebo	Placebo comparator	Drug: PlaceboParticipants received Panel A MK-8189-matching placebo QD for 14 days.
Panel B: Placebo	Placebo comparator	Drug: PlaceboParticipants received Panel B MK-8189-matching placebo for 14 days.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ElpipodectAlso: MK-8189Oral Tablet	Drug	Panel A: 24 mg Elpipodect, Panel B: 16 & 24 mg Elpipodect, Panel C: 8, 16, & 24 mg Elpipodect
PlaceboOral Tablet	Drug	Panel A: Placebo, Panel B: Placebo, Panel C: Placebo

Primary outcome

Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to 28 days
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.
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to 14 days
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.

Results and safety

Results posted to the registry on 17 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Panel A: 24 mg MK-8189	12	12
Panel A: Placebo	5	5
Panel B: 16 & 24 mg MK-8189	0	0
Panel B: Placebo	0	0
Panel C: 8, 16, & 24 mg MK-8189	13	12
Panel C Placebo	4	3

Primary outcome: Number of Participants Who Experience One or More Adverse Events (AEs)

Time frame: Up to 28 days. Number. Unit: Participants

Measure	Panel A: MK-8189 24 mg n = 12	Panel A: Placebo n = 5	Panel B: 16 & 24 mg MK-8189 n = 0	Panel B: Placebo n = 0	Panel C: MK-8189 8 mg n = 13	Panel C: 16 mg MK-8189 n = 13	Panel C: MK-8189 24 mg n = 13	Panel C: MK-8189 12 mg n = 1	Panel C: Placebo n = 4
Value	9	4	–	–	1	4	6	0	1

Population analysed: All participants who received at least one dose of treatment were included in the analysis. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol.

Primary outcome: Number of Participants Who Discontinue Study Treatment Due to an AE

Time frame: Up to 14 days. Number. Unit: Participants

Measure	Panel A: MK-8189 24 mg n = 12	Panel A: Placebo n = 5	Panel B: 16 & 24 mg MK-8189 n = 0	Panel B: Placebo n = 0	Panel C: MK-8189 8 mg n = 13	Panel C: MK-8189 16 mg n = 13	Panel C: MK-8189 24 mg n = 13	Panel C: MK-8189 12 mg n = 1	Panel C: Placebo n = 4
Value	3	1	–	–	0	0	0	0	0

Adverse events

Time frame: Up to 28 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Panel A: MK-8189 24 mg	2 of 12 (16.7%)	9 of 12 (75%)	0 of 12
Panel A: Placebo	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Panel C: MK-8189 8 mg	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
Panel C: MK-8189 16 mg	0 of 13 (0%)	4 of 13 (30.8%)	0 of 13
Panel C: MK-8189 24 mg	0 of 13 (0%)	6 of 13 (46.2%)	0 of 13
Panel C: MK-8189 12 mg	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Panel C: Placebo	0 of 4 (0%)	1 of 4 (25%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Elpipodect in people with Bipolar I Disorder, run by Merck Sharp & Dohme LLC at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experience One or More Adverse Events (AEs) (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06273774.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.