SchizophreniaPhase 1NCT00934466
Study of the Effect of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability (2637-008)
A Phase 1 study testing MK2637, Comparator: MK2637 and Comparator: Dextromethorphan in people with Schizophrenia, run by Merck Sharp & Dohme LLC.
Trial 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. 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
- Schizophrenia
- What is being tested?
- MK2637, Comparator: MK2637 and Comparator: Dextromethorphan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Dec 2009
- 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 right-handed
- Subject is in good health
- Subject is a nonsmoker
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Schizophrenia
- Being tested
- MK2637, Comparator: MK2637, Comparator: Placebo, Comparator: Dextromethorphan
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK2637Drug
Single dose of 120 mg MK2637 capsules in one of five treatment periods.
Comparator: MK2637Drug
Single dose of 50 mg MK2637 capsules in one of five treatment periods.
Comparator: PlaceboDrug
Single dose of placebo only in one of five treatment periods.
Comparator: DextromethorphanDrug
Single dose of 220 mg dextromethorphan capsules in one of five treatment periods.
Comparator: DextromethorphanDrug
Single dose of 110 mg dextromethorphan capsules in one of five treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MK2637 120 mg Receives: Drug: MK2637 |
| 2 | Experimental | MK2637 50 mg Receives: Drug: Comparator: MK2637 |
| 3 | Placebo comparator | Placebo Receives: Drug: Comparator: Placebo |
| 4 | Active comparator | Dextromethorphan 220 mg Receives: Drug: Comparator: Dextromethorphan |
| 5 | Active comparator | Dextromethorphan 110 mg Receives: Drug: Comparator: Dextromethorphan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Motor Evoked Potential (MEP) after dosing with dextromethorphan compared to placebo
Measured: 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
Measured: 4 Hours after initial dosing
Secondary outcomes (2)
Increase in amplitude in the theta frequency band (4-8 Hz) of resting qEEG after dosing with MK2637 compared to placebo
Measured: 6.5 hours after initial dosing
Change in Motor Evoked Potential (MEP) after dosing with MK2637 as compared to placebo
Measured: 5 hours after initial dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 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
- NCT00934466
- Sponsor's protocol ID
- 2637-008
- Other IDs
- MK2637-008, 2009_608
- Status last verified
- Jun 2015
- First submitted
- 6 Jul 2009
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Assess the Effects of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00934466
- Acronym / sponsor ID
- 2637-008
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Jul 2009 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MK2637MK2637 120 mg |
| 2 | Experimental | Drug: Comparator: MK2637MK2637 50 mg |
| 3 | Placebo comparator | Drug: Comparator: PlaceboPlacebo |
| 4 | Active comparator | Drug: Comparator: DextromethorphanDextromethorphan 220 mg |
| 5 | Active comparator | Drug: Comparator: DextromethorphanDextromethorphan 110 mg |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject is right-handed
- Subject is in good health
- Subject is a nonsmoker
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| MK2637Single dose of 120 mg MK2637 capsules in one of five treatment periods. | Drug | 1 |
| Comparator: MK2637Single dose of 50 mg MK2637 capsules in one of five treatment periods. | Drug | 2 |
| Comparator: PlaceboSingle dose of placebo only in one of five treatment periods. | Drug | 3 |
| Comparator: DextromethorphanSingle dose of 220 mg dextromethorphan capsules in one of five treatment periods. | Drug | 4 |
| Comparator: DextromethorphanSingle dose of 110 mg dextromethorphan capsules in one of five treatment periods. | Drug | 5 |
Primary outcome
Increase in Motor Evoked Potential (MEP) after dosing with dextromethorphan compared to placebo
Time frame: 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
Time frame: 4 Hours after initial dosing
2 secondary outcomes
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
Change in Motor Evoked Potential (MEP) after dosing with MK2637 as compared to placebo
Time frame: 5 hours after initial dosing
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 24 Jun 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 MK2637, Comparator: MK2637 and Comparator: Dextromethorphan in people with Schizophrenia, 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 3 inclusion and 3 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 24 Jun 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. Some participants in this study may receive a placebo. 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?
Increase in Motor Evoked Potential (MEP) after dosing with dextromethorphan compared to placebo (time frame: 5 Hours after initial dosing). The study lists 2 primary outcomes in all. 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 24 Jun 2015.