A Study of MK-5720 in Participants With Schizophrenia (MK-5720-001)
Status and phase
Completed
Phase 1
Conditions
Schizophrenia
Treatments
Drug: Placebo to MK-5720
Drug: MK-8189
Drug: MK-5720
Drug: Placebo to MK-8189
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Full description
In Period 1, participants receive once-daily MK-8189 for 7 days, followed by a 72-hour washout. In Period 2, participants receive a single dose of MK-5720.
Enrollment
17 patients
Sex
All
Ages
18 to 60 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Sequential Assignment
Masking
Triple Blind
17 participants in 6 patient groups
Panel A
Experimental group
Description:
Participants received 7 days of oral MK-8189 4 mg or matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 35 mg or a dose matched placebo (Period 2).
Treatment:
Drug: Placebo to MK-8189
Drug: MK-8189
Drug: MK-5720
Drug: Placebo to MK-5720
Panel B
Experimental group
Description:
Participants received 7 days of oral MK-8189 8 mg or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 70 mg or a dose matched placebo (Period 2).
Treatment:
Drug: Placebo to MK-8189
Drug: MK-8189
Drug: MK-5720
Drug: Placebo to MK-5720
Panel C
Experimental group
Description:
Participants received 7 days of oral MK-8189 up to 16 mg or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 up to 140 mg or a dose matched placebo (Period 2).
Treatment:
Drug: Placebo to MK-8189
Drug: MK-8189
Drug: MK-5720
Drug: Placebo to MK-5720
Panel D
Experimental group
Description:
Participants received 7 days of oral MK-8189 up to 24 mg or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 up to 280 mg or a dose matched placebo (Period 2).
Treatment:
Drug: Placebo to MK-8189
Drug: MK-8189
Drug: MK-5720
Drug: Placebo to MK-5720
Panel E
Experimental group
Description:
Participants received 7 days of oral MK-8189 up to 48 mg or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 up to 560 mg or a dose matched placebo (Period 2).
Treatment:
Drug: Placebo to MK-8189
Drug: MK-8189
Drug: MK-5720
Drug: Placebo to MK-5720
Panel F
Experimental group
Description:
Participants received 7 days of oral MK-8189 up to 48 mg or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 up to 560 mg or a dose matched placebo (Period 2), after a Pharmacokinetic (PK) break following Panel E.
Treatment:
Drug: Placebo to MK-8189
Drug: MK-8189
Drug: MK-5720
Drug: Placebo to MK-5720
Trial contacts and locations
4
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Central trial contact
Toll Free Number
Data sourced from clinicaltrials.gov
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