A Randomized Clinical Trial to Assess the Effects of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability in Healthy Subjects

Merck Sharp & Dohme LLC0 sites15 target enrollmentJuly 2009

ConditionsSchizophrenia

InterventionsMK2637

DrugsMK2637 Comparator: MK2637 Comparator: Placebo Comparator: Dextromethorphan

Overview

Phase: Phase 1
Intervention: MK2637
Conditions: Schizophrenia
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 15
Primary Endpoint: Increase in Motor Evoked Potential (MEP) after dosing with dextromethorphan compared to placebo
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study will assess transcranial magnetic stimulation (TMS) as a biomarker and characterize TMS readouts of the activity of MK2637 and dextromethorphan. Resting quantitative electroencephalography(qEEG) readouts are also characterized with MK2637 and dextromethorphan.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

December 2009

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is right-handed
•Subject is in good health
•Subject is a nonsmoker

Exclusion Criteria

•Subject works a night shift
•Subject has a history of any illness that might make participation in the study unsafe or confound the study results
•Subject has a history of head injury

Arms & Interventions

1

MK2637 120 mg

Intervention: MK2637

Outcomes

Primary Outcomes

Increase in Motor Evoked Potential (MEP) after dosing with dextromethorphan compared to placebo

Time Frame: 5 Hours after initial dosing

Increase in amplitude in the gamma frequency band (24-60 Hz) of resting qEEG after dosing with dextromethorphan compared to placebo

Time Frame: 4 Hours after initial dosing

Secondary Outcomes

Change in Motor Evoked Potential (MEP) after dosing with MK2637 as compared to placebo(5 hours after initial dosing)
Increase in amplitude in the theta frequency band (4-8 Hz) of resting qEEG after dosing with MK2637 compared to placebo(6.5 hours after initial dosing)