Approval Probability
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MK-4334 · 1 trial · 1 indication
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...
MK-4334 is an investigational small molecule being developed by Merck & Company, Inc. (ticker MRK) for cognitive impairment associated with schizophrenia. It is in Phase 1 clinical development and has been studied in a single completed trial. It is not an approved medicine.
MK-4334 is being studied as a potential treatment for cognitive impairment associated with schizophrenia. The only completed trial enrolled 38 participants, including healthy volunteers and people with schizophrenia, and used evoked responses as pharmacodynamic biomarkers. The drug remains investigational and is not approved for this or any indication.
MK-4334 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the Phase 1 program studying the compound in cognitive impairment associated with schizophrenia.
MK-4334 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The compound is investigational and has not been approved by the FDA or any other regulator.
MK-4334 has been evaluated in one completed Phase 1 trial, NCT05136690, titled Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007). The trial enrolled 38 participants in the United States, was randomized, double blind, and controlled, and included adults 18 years and older.