DementiaPhase 1NCT01110616
EEG (Electroencephalogram) Platform Standardization in Healthy Male Subjects (3134-010)
A Phase 1 study testing MK3134 and Comparator: Lorazepam in people with Dementia, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- MK3134 and Comparator: Lorazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: A Double Blind, Randomized, Crossover Study to Assess EEG Platform Standardization in Healthy Male Subjects
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.
- Conditions
- Dementia
- Being tested
- MK3134, Comparator: Lorazepam, Comparator: Placebo
- Keywords
- EEG Standardization
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK3134Drug
MK3134, 25 mg tablets (5 x 5 mg capsule), orally
Comparator: LorazepamDrug
Also called Lorazepam
Lorazepam, 2 mg (2 x 1 mg tablet), orally
Comparator: PlaceboDrug
Placebo, to match MK3134, and placebo to match Lorazepam
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | MK3134-Lorazepam-Placebo-MK3134-Lorazepam Receives: Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo |
| Sequence 2 | Experimental | MK3134-Lorazepam-Placebo-Lorazepam-MK3134 Receives: Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo |
| Sequence 3 | Experimental | MK3134-Placebo-Lorazepam-MK3134-Lorazepam Receives: Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo |
| Sequence 4 | Experimental | MK3134-Placebo-Lorazepam-Lorazepam-MK3134 Receives: Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo |
| Sequence 5 | Experimental | Lorazepam-Placebo-MK3134-MK3134-Lorazepam Receives: Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo |
| Sequence 6 | Experimental | Lorazepam-Placebo-MK3134-Lorazepam-MK3134 Receives: Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo |
| Sequence 7 | Experimental | Lorazepam-MK3134-Placebo-MK3134-Lorazepam Receives: Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo |
| Sequence 8 | Experimental | Lorazepam-MK3134-Placebo-Lorazepam-MK3134 Receives: Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo |
| Sequence 9 | Experimental | Placebo-MK3134-Lorazepam-MK3134-Lorazepam Receives: Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo |
| Sequence 10 | Experimental | Placebo-MK3134-Lorazepam-Lorazepam-MK3134 Receives: Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo |
| Sequence 11 | Experimental | Placebo-Lorazepam-MK3134-MK3134-Lorazepam Receives: Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo |
| Sequence 12 | Experimental | Placebo-Lorazepam-MK3134-Lorazepam-MK3134 Receives: Drug: MK3134; Drug: Comparator: Lorazepam; Drug: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG (Electroencephalogram) theta power averaged across a topographical region of interest 6 hours after administration of MK3134/placebo
Measured: Baseline and 6 hours
Secondary outcomes (1)
EEG (Electroencephalogram) beta and sigma power averaged across all cortical leads 2 hours after administration of lorazepam/placebo
Measured: Baseline and 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110616
- Sponsor's protocol ID
- 3134-010
- Other IDs
- MK3134-010
- Status last verified
- Oct 2015
- First submitted
- 22 Apr 2010
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Crossover Study to Assess EEG Platform Standardization in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01110616
- Acronym / sponsor ID
- 3134-010
- Conditions
- Dementia
- Keywords
- EEG Standardization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 26 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: MK3134, Drug: Comparator: Lorazepam, Drug: Comparator: PlaceboMK3134-Lorazepam-Placebo-MK3134-Lorazepam |
| Sequence 2 | Experimental | Drug: MK3134, Drug: Comparator: Lorazepam, Drug: Comparator: PlaceboMK3134-Lorazepam-Placebo-Lorazepam-MK3134 |
| Sequence 3 | Experimental | Drug: MK3134, Drug: Comparator: Lorazepam, Drug: Comparator: PlaceboMK3134-Placebo-Lorazepam-MK3134-Lorazepam |
| Sequence 4 | Experimental | Drug: MK3134, Drug: Comparator: Lorazepam, Drug: Comparator: PlaceboMK3134-Placebo-Lorazepam-Lorazepam-MK3134 |
| Sequence 5 | Experimental | Drug: MK3134, Drug: Comparator: Lorazepam, Drug: Comparator: PlaceboLorazepam-Placebo-MK3134-MK3134-Lorazepam |
| Sequence 6 | Experimental | Drug: MK3134, Drug: Comparator: Lorazepam, Drug: Comparator: PlaceboLorazepam-Placebo-MK3134-Lorazepam-MK3134 |
| Sequence 7 | Experimental | Drug: MK3134, Drug: Comparator: Lorazepam, Drug: Comparator: PlaceboLorazepam-MK3134-Placebo-MK3134-Lorazepam |
| Sequence 8 | Experimental | Drug: MK3134, Drug: Comparator: Lorazepam, Drug: Comparator: PlaceboLorazepam-MK3134-Placebo-Lorazepam-MK3134 |
| Sequence 9 | Experimental | Drug: MK3134, Drug: Comparator: Lorazepam, Drug: Comparator: PlaceboPlacebo-MK3134-Lorazepam-MK3134-Lorazepam |
| Sequence 10 | Experimental | Drug: MK3134, Drug: Comparator: Lorazepam, Drug: Comparator: PlaceboPlacebo-MK3134-Lorazepam-Lorazepam-MK3134 |
| Sequence 11 | Experimental | Drug: MK3134, Drug: Comparator: Lorazepam, Drug: Comparator: PlaceboPlacebo-Lorazepam-MK3134-MK3134-Lorazepam |
| Sequence 12 | Experimental | Drug: MK3134, Drug: Comparator: Lorazepam, Drug: Comparator: PlaceboPlacebo-Lorazepam-MK3134-Lorazepam-MK3134 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK3134MK3134, 25 mg tablets (5 x 5 mg capsule), orally | Drug | Sequence 1, Sequence 10, Sequence 11, Sequence 12, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9 |
| Comparator: LorazepamAlso: LorazepamLorazepam, 2 mg (2 x 1 mg tablet), orally | Drug | Sequence 1, Sequence 10, Sequence 11, Sequence 12, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9 |
| Comparator: PlaceboPlacebo, to match MK3134, and placebo to match Lorazepam | Drug | Sequence 1, Sequence 10, Sequence 11, Sequence 12, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6, Sequence 7, Sequence 8, Sequence 9 |
Primary outcome
EEG (Electroencephalogram) theta power averaged across a topographical region of interest 6 hours after administration of MK3134/placebo
Time frame: Baseline and 6 hours
1 secondary outcome
EEG (Electroencephalogram) beta and sigma power averaged across all cortical leads 2 hours after administration of lorazepam/placebo
Time frame: Baseline and 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK3134 and Comparator: Lorazepam in people with Dementia, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG (Electroencephalogram) theta power averaged across a topographical region of interest 6 hours after administration of MK3134/placebo (time frame: Baseline and 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015.