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MK-5720 + MK-8189 for Schizophrenia

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 12 months
Awards & highlights

Study Summary

This trial evaluates the safety and tolerability of single and multiple doses of two medicines for people with schizophrenia.

Who is the study for?
This trial is for individuals with schizophrenia or schizoaffective disorder, diagnosed at least 2 years ago. Participants must have a history of tolerating antipsychotic medications and can stop their current medication for the study duration. They cannot join if they have severe allergies, metal implants preventing MRI scans, certain infections like HIV or hepatitis, are at risk of self-harm, or have specific psychiatric exclusions.Check my eligibility
What is being tested?
The study tests MK-5720 given as single intramuscular doses and MK-8189 taken orally once daily against placebos to assess safety and how the body processes these drugs in people with schizophrenia. The hypothesis suggests that MK-5720 will be safe and well-tolerated.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects for antipsychotics may include drowsiness, weight gain, dry mouth, restlessness and sometimes more serious effects like movement disorders or metabolic changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC0-inf of MK-8189
Apparent Clearance (CL/F) of MK-5720
Apparent Terminal Half-life (t1/2) of MK-5720
+16 more
Secondary outcome measures
AUC0-28d of MK-8189 in Gluteal Muscle Versus AUC0-28 of MK-8189 in Deltoid Muscle
AUC0-inf of MK-5720 in Gluteal Muscle Versus AUC0-inf of MK-5720 in Deltoid Muscle
AUC0-inf of MK-8189 in Gluteal Muscle Versus AUC0-inf of MK-8189 in Deltoid Muscle
+13 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Panel FExperimental Treatment4 Interventions
Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 6 or a dose matched placebo (Period 2).
Group II: Panel EExperimental Treatment4 Interventions
Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 5 or a dose matched placebo (Period 2).
Group III: Panel DExperimental Treatment4 Interventions
Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 4 or a dose matched placebo (Period 2).
Group IV: Panel CExperimental Treatment4 Interventions
Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 3 or a dose matched placebo (Period 2).
Group V: Panel BExperimental Treatment4 Interventions
Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 2 or a dose matched placebo (Period 2).
Group VI: Panel AExperimental Treatment4 Interventions
Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 at a specified Dose 1 or a dose matched placebo (Period 2).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo to MK-5720
2023
Completed Phase 1
~20
MK-8189
2020
Completed Phase 2
~640
Placebo to MK-8189
2023
Completed Phase 1
~20
MK-5720
2023
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,892 Previous Clinical Trials
5,060,654 Total Patients Enrolled
23 Trials studying Schizophrenia
2,669 Patients Enrolled for Schizophrenia
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,723 Total Patients Enrolled
28 Trials studying Schizophrenia
4,321 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any age restrictions concerning participation in the trial?

"This research seeks out volunteers who are aged 18 and below 60 years old."

Answered by AI

Has Panel A been officially sanctioned by the FDA?

"Our team at Power believes that Panel A can be rated 1 due to the preliminary data collected during Phase 1, which is only indicative of its potential safety and efficacy."

Answered by AI

Are any fresh participants being accepted for this experiment?

"Affirmative. Information available on clinicaltrials.gov indicates that this medical trial, originally posted in September 15th 2023, is currently accepting applicants. Approximately 64 patients have to be recruited from two separate locations."

Answered by AI

How many participants have signed up for this experiment thus far?

"Affirmative. According to clinicaltrials.gov, enrollment for this medical trial is still open and began on September 15th 2023. The last edit was made 6 days later on the 21st of the same month. 64 individuals are required between two sites."

Answered by AI

Could I potentially join this research endeavor?

"This research involves 64 individuals diagnosed with schizophrenia that are between 18 and 60. To qualify, participants must meet the DSM-5 criteria for a minimum of two years before their screening appointment, have a history of tolerating antipsychotic medications at regular doses, and not take any medication five days or more (or three half-lives) prior to beginning the intervention."

Answered by AI

What beneficial effects does this investigation seek to achieve?

"This clinical trial, which shall measure results over a 12 month time frame, is aimed at determining the number of participants that experience one or more adverse events during Period 2. Secondary objectives include comparing the area under concentration-time curves (AUC0-28 and AUC0-inf) for MK-8189 in gluteal muscles versus deltoid muscle as well as assessing the maximum concentrations (Cmax) of MK-8189 after administration in both musculature regions."

Answered by AI
~11 spots leftby Apr 2025