A Study of Elpipodect (MK-8189) in Participants With Schizophrenia (MK-8189-014)

NCT05406440 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 8189-014MK-8189-014
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 3

Brief Summary

The primary purpose of this study is to assess the safety and tolerability of multiple ascending doses of elpipodect in participants with schizophrenia.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing an Adverse Event (AE)

  An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced one or more AEs were reported.

  Up to approximately 17 days

• Number of Participants Who Discontinue From Study Treatment Due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinued study due to an AE were reported.

  Up to approximately 3 days

Study Arms (4)

Elpipodect Panel A

EXPERIMENTAL

Participants will receive elpipodect starting at 48 mg on Day 1 and 60 mg on Day 2.

Drug: Elpipodect

Elpipodect Panel A-1

EXPERIMENTAL

Participants will receive elpipodect 48 mg on Day 1 and 80 mg on Day 2.

Drug: Elpipodect

Elpipodect Panel C

EXPERIMENTAL

Participants will receive elpipodect 48 mg on Days 1-2 and 80 mg on Day 3 based on safety and tolerability.

Drug: Elpipodect

Placebo

PLACEBO COMPARATOR

Participants will receive MK-8189-matching placebo.

Drug: Placebo

Interventions

Placebo DRUG

MK-8189 dose-matching placebo tablets will be administered orally QD.

Placebo

Elpipodect DRUG

MK-8189 4 mg and/or 12 mg tablet(s) will be administered orally QD for a total daily dose of 48 mg, 60 mg, 80 mg.

Also known as: MK-8189

Elpipodect Panel A; Elpipodect Panel A-1; Elpipodect Panel C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Meets diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria with the onset of the first episode being no less than 2 years prior to screening and monotherapy with antipsychotics for treatment should be indicated.
• Is in the non-acute phase of their illness and clinically stable for 3 months prior to screening as demonstrated by: 1) no clinically significant change in dose of prescribed antipsychotic medication, or clinically significant change in antipsychotic medication to treat symptoms of schizophrenia for two months prior to screening; 2) no increase in level of psychiatric care due to worsening of symptoms of schizophrenia for three months prior to screening.
• Has a history of receiving and tolerating antipsychotic medication within the usual dose range employed for schizophrenia.
• Is able to discontinue the use of all antipsychotic medication at least 5 days or 3 half-lives (whichever is longer) prior to Day -1 and during the study period.
• Is at imminent risk of self-harm.
• Has a history of cancer (malignancy). Exceptions: 1) adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix; 2) malignancies which have been successfully treated ≥10 years prior to the prestudy (screening) visit; 3) highly unlikely to sustain a recurrence for the duration of the study.
• Has evidence or history of a primary DSM-5 axis I psychiatric diagnosis other than schizophrenia or schizoaffective disorder per the allowed DSM-5 criteria within one month of screening.
• Has evidence or history of mental retardation, borderline personality disorder, anxiety disorder, or organic brain syndrome.
• Has a history of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia.
• Has a substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse.
• Has a DSM-5 defined substance use disorder (excluding nicotine and caffeine) within 3 months of screening.
• Has a history of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures.
• Has a clinically significant history or presence of sick sinus syndrome, first, second, or third degree atrioventricular (AV) block, myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged corrected QT (QTc) interval, or conduction abnormalities.
• Meets any of the following cardiac parameters: a history of risk factors for Torsades de Pointes (eg, heart failure/cardiomyopathy or family history of long QT syndrome), uncorrected hypokalemia or hypomagnesemia, or is taking concomitant medications that prolong the QT/QTc interval.
• Has history of repeated or frequent syncope, vasovagal episodes, or epileptic seizures.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (3)

Collaborative Neuroscience Research, LLC ( Site 0004)

Garden Grove, California, 92845, United States

Location

California Clinical Trials Medical Group managed by PAREXEL ( Site 0002)

Glendale, California, 91206, United States

Location

Hassman Research Institute Marlton Site ( Site 0003)

Marlton, New Jersey, 08053, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Schizophrenia

Interventions

MK-8189

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 6, 2022
• Study Start: July 12, 2022
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: April 29, 2026
• Results First Posted: July 25, 2024

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)