NCT05953740CompletedPhase 1
A Study of MK-5720 in Participants With Schizophrenia (MK-5720-001)
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Long-Acting Injectable of MK-5720 in Participants With Schizophrenia
Source: ClinicalTrials.gov · Last updated 4 Mar 2025
Brief summary (registry, in English)
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending intramuscular doses of MK-5720, and the safety and tolerability of multiple once-daily oral doses of MK-8189, in participants with schizophrenia. The primary study hypothesis is that the administration of MK-5720 is safe and well tolerated.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 12 Jul 2023
- Start date
- 15 Sept 2023
- Primary completion date
- 15 Feb 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Schizophrenia
- NCT number
- NCT05953740
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 17
- From 15 Sept 2023 to the primary completion date, 15 Feb 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has a history of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures
- Has a metallic implant of any sort that prevents MRI examination, or any other contraindication to MRI examination
- Has received or is currently receiving treatment with clozapine for any length of time
- Has received any live vaccines within 30 days prior to the first dose of study intervention or is scheduled to receive any live vaccine through 60 days following study intervention
Other illness
- Has history of mental retardation, borderline personality 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 family history of sudden death
- History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
- Positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
Other
- The main exclusion criteria include but are not limited to the following:
- Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator
- Has claustrophobia to a degree that prevents tolerance of magnetic resonance imaging (MRI) scanning procedure
- Presents any concern by the investigator regarding safe participation in the study or for any other reason the investigator considers the participant inappropriate for participation in the study
Who the study is looking for
- The main inclusion criteria include but are not limited to the following:
- Meets diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (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
- Has a history of receiving and tolerating antipsychotics medication within the usual dose range employed for schizophrenia
- Can discontinue the use of all antipsychotic medication at least 5 days or 3 half-lives (which ever in longer) prior to the start of the treatment period and during the study
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| California Clinical Trials Medical Group managed by PAREXEL ( Site 0003) Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Velocity Clinical Research, Hallandale Beach ( Site 0002) Coordinator of this site? Confirm its status | Hallandale | United States | Unknown status |
| Research Centers of America ( Hollywood ) ( Site 0001) Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Hassman Research Institute Marlton Site ( Site 0007) Coordinator of this site? Confirm its status | Marlton | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.