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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: MK2637; Drug: Comparator: MK2637; Drug: Comparator: Placebo; Drug: Comparator: Dextromethorphan; Drug: Comparator: Dextromethorphan

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 3; Placebo	Drug: Comparator: Placebo; Single dose of placebo only in one of five treatment periods.
Experimental: 1; MK2637 120 mg	Drug: MK2637; Single dose of 120 mg MK2637 capsules in one of five treatment periods.
Experimental: 2; MK2637 50 mg	Drug: Comparator: MK2637; Single dose of 50 mg MK2637 capsules in one of five treatment periods.
Active Comparator: 4; Dextromethorphan 220 mg	Drug: Comparator: Dextromethorphan; Single dose of 220 mg dextromethorphan capsules in one of five treatment periods.; Drug: Comparator: Dextromethorphan; Single dose of 110 mg dextromethorphan capsules in one of five treatment periods.
Active Comparator: 5; Dextromethorphan 110 mg	Drug: Comparator: Dextromethorphan; Single dose of 220 mg dextromethorphan capsules in one of five treatment periods.; Drug: Comparator: Dextromethorphan; Single dose of 110 mg dextromethorphan capsules in one of five treatment periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Increase in Motor Evoked Potential (MEP) after dosing with dextromethorphan compared to placebo	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	4 Hours after initial dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change in Motor Evoked Potential (MEP) after dosing with MK2637 as compared to placebo	5 hours after initial dosing

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: July 6, 2009
• First Submitted That Met QC Criteria: July 7, 2009
• First Posted (Estimate): July 8, 2009

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 23, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Respiratory System Agents; Antitussive Agents; Dextromethorphan
• Other Study ID Numbers: 2637-008; MK2637-008; 2009_608