Phase 1
Completed N=17
A Study of MK-5720 in Participants With Schizophrenia (MK-5720-001)
Source: ClinicalTrials.gov NCT05953740 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Number of Participants Who Experience ≥1 Adverse Event (AE) in Period 1 — 1; 4; 2 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience ≥1 Adverse Event (AE) in Period 1 |
1; 4; 2 | — |
| PRIMARY Number of Participants Who Experience ≥1 AE(s) in Period 2 |
1; 2; 1 | — |
| PRIMARY Number of Participants Who Discontinue Study Due to an AE in Period 1 |
0; 1; 0 | — |
| PRIMARY Number of Participants Who Discontinue Study Due to an AE in Period 2 |
0; 0; 0 | — |
| PRIMARY Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of MK-5720 |
34.3; 73.3 | — |
| PRIMARY Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC-inf) of MK-5720 |
70.0; 134 | — |
| PRIMARY Maximum Serum Concentration (Cmax) of MK-5720 |
0.165; 0.473 | — |
| PRIMARY Time to Maximum Concentration (Tmax) of MK-5720 |
48.00; 108.00 | — |
| PRIMARY Apparent Clearance (CL/F) of MK-5720 |
892; 933 | — |
| PRIMARY Apparent Volume of Distribution (Vz/F) of MK-5720 |
55400; 218000 | — |
| PRIMARY Apparent Terminal Half-life (t1/2) of MK-5720 |
43.0; 162 | — |
| PRIMARY Area Under the Concentration-Time Curve From Time 0 to 28 Days (AUC0-28d) of MK-8189 |
2850; 29800 | — |
| PRIMARY AUC0-inf of MK-8189 |
8400; 31900 | — |
| PRIMARY Cmax of MK-8189 |
18.8; 104 | — |
| PRIMARY Tmax of MK-8189 |
96.00; 120.00 | — |
| PRIMARY Concentration at Day 28 (C28d) of MK-8189 |
NA; 2.96 | — |
| PRIMARY CL/F of MK-8189 |
7.43; 3.92 | — |
| PRIMARY Vz/F of MK-8189 |
697; 593 | — |
| PRIMARY t1/2 of MK-8189 |
65.0; 105 | — |
| SECONDARY Panels D, E, and F: C28d Tied to Specific Exposures of MK-8189 |
— | — |
| SECONDARY Panels C, D, E, and F: AUC0-28d of MK-8189 in Gluteal Muscle Versus AUC0-28 of MK-8189 in Deltoid Muscle |
— | — |
| SECONDARY Panels C, D, E, and F: AUC0-inf of MK-8189 in Gluteal Muscle Versus AUC0-inf of MK-8189 in Deltoid Muscle |
— | — |
| SECONDARY Panels C, D, E, and F: Cmax of MK-8189 in Gluteal Muscle Versus Cmax of MK-8189 in Deltoid Muscle |
— | — |
| SECONDARY Panels C, D, E, and F: Tmax of MK-8189 in Gluteal Muscle Versus Tmax of MK-8189 in Deltoid Muscle |
— | — |
| SECONDARY Panels C, D, E, and F: C28d of MK-8189 in Gluteal Muscle Versus C28d in Deltoid Muscle |
— | — |
| SECONDARY Panels C, D, E, and F: CL/F of MK-8189 in Gluteal Muscle Versus CL/F in Deltoid Muscle |
— | — |
| SECONDARY Panels C, D, E, and F: Vz/F of MK-8189 in Gluteal Muscle Versus Vz/F of MK-8189 in Deltoid Muscle |
— | — |
| SECONDARY Panels C, D, E, and F: t1/2 of MK-8189 in Gluteal Muscle Versus t1/2 of MK-8189 in Deltoid Muscle |
— | — |
| SECONDARY Panels C, D, E, and F: AUC0-last of MK 5720 in Gluteal Muscle Versus AUC0-last of MK-5720 in Deltoid Muscle |
— | — |
| SECONDARY Panels C, D, E, and F: AUC0-inf of MK-5720 in Gluteal Muscle Versus AUC0-inf of MK-5720 in Deltoid Muscle |
— | — |
| SECONDARY Panels C, D, E, and F: Cmax of MK-5720 in Gluteal Muscle Versus Cmax of MK-5720 in Deltoid Muscle |
— | — |
| SECONDARY Panels C, D, E, and F: Tmax of MK-5720 in Gluteal Muscle Versus Tmax of MK-5720 in Deltoid Muscle |
— | — |
| SECONDARY Panels C, D, E, and F: CL/F of MK-5720 in Gluteal Muscle Versus CL/F of MK-5720 in Deltoid Muscle |
— | — |
| SECONDARY Panels C, D, E, and F: Vz/F of MK-5720 in Gluteal Muscle Versus Vz/F of MK-5720 in Deltoid Muscle |
— | — |
| SECONDARY Panels C, D, E, and F: t1/2 of MK-5720 in Gluteal Muscle Versus t1/2 of MK-5720 in Deltoid Muscle |
— | — |
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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 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 history of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures
- Has a family history of sudden death
- Has claustrophobia to a degree that prevents tolerance of magnetic resonance imaging (MRI) scanning procedure
- Has a metallic implant of any sort that prevents MRI examination, or any other contraindication to MRI examination
- 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
- 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)
- 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
Data sourced from ClinicalTrials.gov (NCT05953740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.