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Study of the Effect of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability (2637-008)

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00934466
Enrollment
15
Registered
2009-07-08
Start date
2009-07-31
Completion date
2009-12-31
Last updated
2015-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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.

Interventions

DRUGMK2637

Single dose of 120 mg MK2637 capsules in one of five treatment periods.

DRUGComparator: MK2637

Single dose of 50 mg MK2637 capsules in one of five treatment periods.

DRUGComparator: Placebo

Single dose of placebo only in one of five treatment periods.

DRUGComparator: Dextromethorphan

Single dose of 220 mg dextromethorphan capsules in one of five treatment periods.

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Increase in Motor Evoked Potential (MEP) after dosing with dextromethorphan compared to placebo5 Hours after initial dosing
Increase in amplitude in the gamma frequency band (24-60 Hz) of resting qEEG after dosing with dextromethorphan compared to placebo4 Hours after initial dosing

Secondary

MeasureTime frame
Increase in amplitude in the theta frequency band (4-8 Hz) of resting qEEG after dosing with MK2637 compared to placebo6.5 hours after initial dosing
Change in Motor Evoked Potential (MEP) after dosing with MK2637 as compared to placebo5 hours after initial dosing

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026