Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)
Cognitive Impairment Associated With Schizophrenia
About this trial
This is an interventional basic science trial for Cognitive Impairment Associated With Schizophrenia
Eligibility Criteria
Inclusion Criteria:
HC Participants:
- Is in generally good health
- Has no history of clinically relevant neuropsychiatric illness
- Is a mild-to-moderate tobacco user of ≥1-year duration, smoking the equivalent of ~10-15 cigarettes/day
Participants with Mild-to-Moderate SZ:
- Has a current diagnosis of SZ with a duration ≥1 year
- Is clinically stable and in the residual (non-acute) phase of illness for ≥12 weeks prior to the study
- Is stably maintained on a regimen of up to 2 first- or second-generation antipsychotics with no dose changes >50% in combination with concomitant medication commonly prescribed to this population for ≥8 weeks prior to screening and during the study
- Is a mild-to-moderate tobacco user of ≥1-year duration, smoking the equivalent of ~10-15 cigarettes/day
All Participants:
- For males, agrees to be abstinent from heterosexual intercourse, or use an approved contraception method, during the study and for 90 days after the last dose of study drug
- For females, is not of childbearing potential
- Is willing to comply with restrictions on the use of nicotine or nicotine-containing products during the study
Exclusion Criteria:
HC Participants:
- Has known biological family history of psychotic disorder in a first or second degree relative
Participants with Mild-to-Moderate SZ:
- May be excluded from participation by the investigator based on treatment history and/or performance on various screening tests
All Participants:
- Is positive for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV)
- Is at imminent risk of self-harm
- Has had major surgery or donated blood within 4 weeks prior to screening
- Has evidence of cognitive impairment or significant mental disability
- Has a history of clinically significant abnormality or disease
- Has a history of cancer (malignancy)
- Is unable to refrain, or anticipates use, of any non-prescription drugs or herbal remedies
- Has participated in another clinical study within 6 weeks or 5 half-lives (whichever is greater) prior to screening
Sites / Locations
- Collaborative Neuroscience Research, LLC ( Site 0002)
- Hassman Research Institute Marlton Site ( Site 0001)
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Panel A: Healthy Control Participants
Panel B: Participants with Mild-to-Moderate SZ
In Part 1, HC participants receive nicotine patch + capsule placebo, and patch placebo + capsule placebo, under a cross-over design in Periods 1 and 2. In Part 2 (Period 3), HC participants are randomly assigned to receive either MK-4334 250 mg capsule + patch placebo or capsule placebo + patch placebo.
In Part 1, participants with mild-to-moderate SZ receive nicotine patch + capsule placebo, and patch placebo + capsule placebo, under a cross-over design in Periods 1 and 2. In Part 2 (Period 3), SZ participants are randomly assigned to receive either MK-4334 250 mg capsule + patch placebo or capsule placebo + patch placebo.