EEG (Electroencephalogram) Platform Standardization in Healthy Male Subjects (3134-010)
Overview[ - collapse ][ - ]
| Purpose | The objective of this study is to test the experimental reproducibility and within-subject variability of qEEG (quantitative electroencephalogram) using two probe compounds: MK3134 and lorazepam. This study will test the hypothesis that EEG (Electroencephalogram) theta power, averaged across a topographical region of interest is decreased 6 hours after administration of MK3134 compared to placebo. The objective of this study is to test the experimental reproducibility and within-subject variability of qEEG using two probe compounds: MK3134 and lorazepam. |
|---|---|
| Condition | Dementia |
| Intervention | Drug: MK3134 Drug: Comparator: Lorazepam Drug: Comparator: Placebo |
| Phase | Phase 1 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT01110616 |
| First Received | April 22, 2010 |
| Last Updated | January 27, 2011 |
| Last verified | January 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 22, 2010 |
|---|---|
| Last Updated Date | January 27, 2011 |
| Start Date | June 2010 |
| Estimated Primary Completion Date | October 2010 |
| Current Primary Outcome Measures | EEG (Electroencephalogram) theta power averaged across a topographical region of interest 6 hours after administration of MK3134/placebo [Time Frame: Baseline and 6 hours] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | EEG (Electroencephalogram) beta and sigma power averaged across all cortical leads 2 hours after administration of lorazepam/placebo [Time Frame: Baseline and 2 hours] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | EEG (Electroencephalogram) Platform Standardization in Healthy Male Subjects (3134-010) |
|---|---|
| Official Title | A Double Blind, Randomized, Crossover Study to Assess EEG Platform Standardization in Healthy Male Subjects |
| Brief Summary | The objective of this study is to test the experimental reproducibility and within-subject variability of qEEG (quantitative electroencephalogram) using two probe compounds: MK3134 and lorazepam. This study will test the hypothesis that EEG (Electroencephalogram) theta power, averaged across a topographical region of interest is decreased 6 hours after administration of MK3134 compared to placebo. The objective of this study is to test the experimental reproducibility and within-subject variability of qEEG using two probe compounds: MK3134 and lorazepam. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Dementia |
| Intervention | Drug: MK3134 MK3134, 25 mg tablets (5 x 5 mg capsule), orally Other Names: MK3134Drug: Comparator: Lorazepam Lorazepam, 2 mg (2 x 1 mg tablet), orally Other Names: LorazepamDrug: Comparator: Placebo Placebo, to match MK3134, and placebo to match Lorazepam |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 25 |
| Estimated Completion Date | October 2010 |
| Estimated Primary Completion Date | October 2010 |
| Eligibility Criteria | Inclusion Criteria: - Subject is a male between 18 to 40 years of age - The subject has a Body Mass Index (BMI) greater than or equal to 31 kg/m^2 at the prestudy (screening) visit - Subject has normal or corrected to normal visual and auditory acuity - Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months - Subject is right-handed Exclusion Criteria: - Subject has permanent cosmetic or metallic objects in their body that can interfere with the measurements - Subject has a history of stroke, chronic seizures, or major neurological disorder - Subject has a history of neoplastic disease - Subject has a current diagnosis of or a prior history of sleep apnea - Subject has a history of fainting during blood draws - Subject has a history of significant head injury/trauma - Subject has a current diagnosis of or history of Bipolar illness, Schizophrenia, Attention Deficit Hyperactivity Disorder (ADHD), or claustrophobia - Subject works a night shift and is not able to avoid night shift work within 3 days before each treatment visit - Subject is currently a regular user of any illicit drugs or has a significant history of drug (including alcohol) abuse |
| Gender | Male |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01110616 |
|---|---|
| Other Study ID Numbers | 2010_529 |
| Has Data Monitoring Committee | No |
| Information Provided By | Merck Sharp & Dohme Corp. |
| Study Sponsor | Merck Sharp & Dohme Corp. |
| Collaborators | Not Provided |
| Investigators | Study Director: Medical Monitor Merck Sharp & Dohme Corp. |
| Verification Date | January 2011 |