MigrainePhase 1NCT00965887
Bioequivalence of Two Tablet Forms of MK0974 (0974-045)
A Phase 1 study testing MK0974 Ethanolate formulation and Comparator: MK0974 Hydrate formulation in people with Migraine, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate the bioequivalence of two solid dose formulations of MK0974. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- MK0974 Ethanolate formulation and Comparator: MK0974 Hydrate formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to May 2008
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is in good health
- Subject is a non-smoker
- Subject is willing to comply with the study restrictions
Who cannot join
- Subject has a history of stroke, chronic seizures, or major neurological disorder
- Subject has a history of cancer
- Subject is a nursing mother
- Subject has or has a history of any disease or condition that might make participation in the study unsafe or that might confound the results of the study
About this study
Official title: An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Bioequivalence of a Single Dose of a Tablet Form of MK0974 Ethanolate vs. a Single Dose of a Tablet Form of MK0974 Hydrate in Healthy Subjects
This study will evaluate the bioequivalence of two solid dose formulations of MK0974.
- Conditions
- Migraine
- Being tested
- MK0974 Ethanolate formulation, Comparator: MK0974 Hydrate formulation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0974 Ethanolate formulationDrug
Single dose MK0974 280 mg tablet in one of two treatment periods
Comparator: MK0974 Hydrate formulationDrug
Single dose MK0974 280 mg tablet in one of two treatment periods
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | MK0974 Ethanolate Receives: Drug: MK0974 Ethanolate formulation |
| 2 | Active comparator | MK0974 Hydrate Receives: Drug: Comparator: MK0974 Hydrate formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC(0 to infinity) following single dose administration of MK0974 ethanolate or hydrate formulations
Measured: Through 48 hours postdose
Peak plasma concentration (Cmax) following single dose administration of MK0974 ethanolate or hydrate formulations
Measured: Through 48 Hours Post Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startMar 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- None (open label)
- Enrolment
- 36 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
- NCT00965887
- Sponsor's protocol ID
- 0974-045
- Other IDs
- MK0974-045, 2009_650
- Status last verified
- Jul 2015
- First submitted
- 24 Aug 2009
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Bioequivalence of a Single Dose of a Tablet Form of MK0974 Ethanolate vs. a Single Dose of a Tablet Form of MK0974 Hydrate in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00965887
- Acronym / sponsor ID
- 0974-045
- Conditions
- Migraine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 26 Aug 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 evaluate the bioequivalence of two solid dose formulations of MK0974.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: MK0974 Ethanolate formulationMK0974 Ethanolate |
| 2 | Active comparator | Drug: Comparator: MK0974 Hydrate formulationMK0974 Hydrate |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject is in good health
- Subject is a non-smoker
- Subject is willing to comply with the study restrictions
Key exclusion criteria (4 listed)
- Subject has a history of stroke, chronic seizures, or major neurological disorder
- Subject has a history of cancer
- Subject is a nursing mother
- Subject has or has a history of any disease or condition that might make participation in the study unsafe or that might confound the results of the study
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 |
|---|---|---|
| MK0974 Ethanolate formulationSingle dose MK0974 280 mg tablet in one of two treatment periods | Drug | 1 |
| Comparator: MK0974 Hydrate formulationSingle dose MK0974 280 mg tablet in one of two treatment periods | Drug | 2 |
Primary outcome
Area under the curve (AUC(0 to infinity) following single dose administration of MK0974 ethanolate or hydrate formulations
Time frame: Through 48 hours postdose
Peak plasma concentration (Cmax) following single dose administration of MK0974 ethanolate or hydrate formulations
Time frame: Through 48 Hours Post Dose
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 7 Jul 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 MK0974 Ethanolate formulation and Comparator: MK0974 Hydrate formulation in people with Migraine, 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 4 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 7 Jul 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?
Area under the curve (AUC(0 to infinity) following single dose administration of MK0974 ethanolate or hydrate formulations (time frame: Through 48 hours postdose). 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 7 Jul 2015.