Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05136690 | Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007) | PHASE1 | COMPLETED | 38 | — | — | Apr 27, 2022 | Nov 4, 2022 | Nov 29, 2024 | 2 | United States |
The ITC magnitude derived from the 40Hz ASSR is presented. ASSR is measured following a short stream of click trains with a 500 msec inter-train interval (duration), at standard tone and at 40Hz tone. The magnitude of ITC represents the phase consistency of oscillatory activities, in response to EEG coherence at 40Hz stimulation. ITC as a unit of measure is expressed as frequency (40Hz) vs time (msec).
| Arm | Type | Description |
|---|---|---|
| Panel A: Healthy Control Participants | EXPERIMENTAL | 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. |
| Panel B: Participants with Mild-to-Moderate SZ | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Nicotine patch | DRUG | Nicotine 21 mg transdermal nicotine patch. |
| MK-4334 | DRUG | MK-4334 250 mg capsule taken by mouth. |
| Placebo patch | DRUG | Placebo patch. |
| Placebo capsule | DRUG | Placebo capsule taken by mouth. |
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 di...