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Completed

NCT Number: NCT00934466

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK2637

Drug

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

Comparator: MK2637

Drug

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

Comparator: placebo

Drug

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

Comparator: Dextromethorphan

Drug

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

Primary outcomes

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

    Time frame: 5 Hours after initial dosing

  2. 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

  1. Increase in amplitude in the theta frequency band (4-8 Hz) of resting qEEG after dosing with MK2637 compared to placebo

    Time frame: 6.5 hours after initial dosing

  2. Change in Motor Evoked Potential (MEP) after dosing with MK2637 as compared to placebo

    Time frame: 5 hours after initial dosing

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 8, 2009
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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