InsomniaPhase 1NCT01311882
A Study to Evaluate Next Day Effects of MK-4305 on Driving Performance (MK-4305-035 AM1)
A Phase 1 study testing MK-4305 40 mg, MK-4305 20 mg and Zopiclone in people with Insomnia, run by Merck Sharp & Dohme LLC at 1 site in Netherlands.
Trial summary
This is a study to evaluate next-day residual effects of MK-4305 on highway driving performance in healthy, non-elderly participants. Read more about this study
- Who is it for?
- Ages 21 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- MK-4305 40 mg, MK-4305 20 mg and Zopiclone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2011to Nov 2011
- 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 21 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female participants of reproductive potential must agree to use (and/or have their partner use) acceptable methods of birth control beginning at least 2 weeks prior to the administration of the first dose of study drug throughout the study
- Has a body mass index (BMI) within the range of 18 to 30 kg/m^2
- Possesses a valid driver's license for 3 years or more with at least 5000 km/year on average within the last 3 years
- Is capable of driving a manual transmission vehicle and is willing to drive on a highway
- Is judged to be in good health
- Has a regular sleep pattern
- Is not visually impaired
Who cannot join
- Has a history of a persistent sleep abnormality
- Has neurological disease/cognitive impairment
- Has a history of cataplexy
- Is a regular user of sedative-hypnotic agents
- Is allergic to zopiclone
- Has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study start and will travel across 3 or more time zones throughout study duration
Show all 9Show fewer
- Works a night shift and is not able to avoid night shift work within 1 week before each treatment visit
- Is pregnant or nursing
- Does not qualify as a proficient driver according to the driving instructors evaluation of subject's driving on the driving test practice session
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple Dose Study to Evaluate Next Day Effects of MK-4305 on Driving Performance in Healthy Non-Elderly Subjects
This is a study to evaluate next-day residual effects of MK-4305 on highway driving performance in healthy, non-elderly participants.
- Conditions
- Insomnia
- Being tested
- MK-4305 40 mg, MK-4305 20 mg, Zopiclone, Grossly Matching Placebo for Zopiclone, Matching Placebo for MK-4305
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-4305 40 mgDrug
4 x 10 mg MK-4305 tablets
MK-4305 20 mgDrug
2 x 10 mg MK-4305 tablets
ZopicloneDrug
Also called Zimovane
1 x 7.5 mg Zopiclone tablet
Grossly Matching Placebo for ZopicloneDrug
Grossly Matching Placebo for Zopiclone
Matching Placebo for MK-4305Drug
Matching Placebo for MK-4305
| Study group | Role | What they receive |
|---|---|---|
| MK-4305 40 mg | Experimental | Day 1 and Day 8- 4 x 10 mg MK-4305 and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 4 x 10 mg MK-4305 Receives: Drug: MK-4305 40 mg; Drug: Grossly Matching Placebo for Zopiclone |
| MK-4305 20 mg | Experimental | Day 1 and Day 8- 2 x 10 mg MK-4305 and 2 x 10 mg MK-4305 matching placebo and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 2 x 10 mg MK-4305 and 2 x 10 mg MK-4305 matching placebo Receives: Drug: MK-4305 20 mg; Drug: Grossly Matching Placebo for Zopiclone; Drug: Matching Placebo for MK-4305 |
| Zopiclone 7.5 mg | Active comparator | Day 1 and Day 8- 1 x 7.5 mg zopiclone and 4 x 10 mg MK-4305 matching placebo; Days 2-7- 4 x 10 mg MK-4305 matching placebo Receives: Drug: Zopiclone; Drug: Matching Placebo for MK-4305 |
| Placebo | Placebo comparator | Day 1 and Day 8- 4 x 10 mg MK-4305 matching placebo and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 4 x 10 mg MK-4305 matching placebo Receives: Drug: Grossly Matching Placebo for Zopiclone; Drug: Matching Placebo for MK-4305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo
Measured: Day 2
Secondary outcomes (8)
Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo
Measured: Day 2
Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo
Measured: Day 9
Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo
Measured: Day 9
Mean standard deviation of speed (SDS) on highway driving (MK-4305 versus placebo)
Measured: Day 2 and Day 9
Word learning test (MK-4305 versus placebo)
Measured: Day 2 and Day 9
Body sway area: Area of the 95% confidence ellipse enclosing the center of pressure (A95) (MK-4305 versus placebo)
Measured: Day 2 and Day 9
Number of participants with adverse events
Measured: Up to 14 days after last dose
Number of participants discontinued from study due to adverse events
Measured: Up to 14 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311882
- Sponsor's protocol ID
- 4305-035
- Status last verified
- Feb 2016
- First submitted
- 8 Mar 2011
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Vermeeren A, Sun H, Vuurman EF, Jongen S, Van Leeuwen CJ, Van Oers AC, Palcza J, Li X, Laethem T, Heirman I, Bautmans A, Troyer MD, Wrishko R, McCrea J. On-the-Road Driving Performance the Morning after Bedtime Use of Suvorexant 20 and 40 mg: A Study in Non-Elderly Healthy Volunteers. Sleep. 2015 Nov 1;38(11):1803-13. doi: 10.5665/sleep.5168.
PubMed 26039969
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Study to Evaluate Next Day Effects of MK-4305 on Driving Performance in Healthy Non-Elderly Subjects
- ClinicalTrials.gov ID
- NCT01311882
- Acronym / sponsor ID
- 4305-035
- Conditions
- Insomnia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 10 Mar 2011 (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 is a study to evaluate next-day residual effects of MK-4305 on highway driving performance in healthy, non-elderly participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MK-4305 40 mg | Experimental | Drug: MK-4305 40 mg, Drug: Grossly Matching Placebo for ZopicloneDay 1 and Day 8- 4 x 10 mg MK-4305 and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 4 x 10 mg MK-4305 |
| MK-4305 20 mg | Experimental | Drug: MK-4305 20 mg, Drug: Grossly Matching Placebo for Zopiclone, Drug: Matching Placebo for MK-4305Day 1 and Day 8- 2 x 10 mg MK-4305 and 2 x 10 mg MK-4305 matching placebo and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 2 x 10 mg MK-4305 and 2 x 10 mg MK-4305 matching placebo |
| Zopiclone 7.5 mg | Active comparator | Drug: Zopiclone, Drug: Matching Placebo for MK-4305Day 1 and Day 8- 1 x 7.5 mg zopiclone and 4 x 10 mg MK-4305 matching placebo; Days 2-7- 4 x 10 mg MK-4305 matching placebo |
| Placebo | Placebo comparator | Drug: Grossly Matching Placebo for Zopiclone, Drug: Matching Placebo for MK-4305Day 1 and Day 8- 4 x 10 mg MK-4305 matching placebo and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 4 x 10 mg MK-4305 matching placebo |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female participants of reproductive potential must agree to use (and/or have their partner use) acceptable methods of birth control beginning at least 2 weeks prior to the administration of the first dose of study drug throughout the study
- Has a body mass index (BMI) within the range of 18 to 30 kg/m^2
- Possesses a valid driver's license for 3 years or more with at least 5000 km/year on average within the last 3 years
- Is capable of driving a manual transmission vehicle and is willing to drive on a highway
- Is judged to be in good health
Key exclusion criteria (9 listed)
- Has a history of a persistent sleep abnormality
- Has neurological disease/cognitive impairment
- Has a history of cataplexy
- Is a regular user of sedative-hypnotic agents
- Is allergic to zopiclone
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 |
|---|---|---|
| MK-4305 40 mg4 x 10 mg MK-4305 tablets | Drug | MK-4305 40 mg |
| MK-4305 20 mg2 x 10 mg MK-4305 tablets | Drug | MK-4305 20 mg |
| ZopicloneAlso: Zimovane1 x 7.5 mg Zopiclone tablet | Drug | Zopiclone 7.5 mg |
| Grossly Matching Placebo for ZopicloneGrossly Matching Placebo for Zopiclone | Drug | MK-4305 20 mg, MK-4305 40 mg, Placebo |
| Matching Placebo for MK-4305Matching Placebo for MK-4305 | Drug | MK-4305 20 mg, Placebo, Zopiclone 7.5 mg |
Primary outcome
Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo
Time frame: Day 2
8 secondary outcomes
Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo
Time frame: Day 2
Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo
Time frame: Day 9
Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo
Time frame: Day 9
Mean standard deviation of speed (SDS) on highway driving (MK-4305 versus placebo)
Time frame: Day 2 and Day 9
Word learning test (MK-4305 versus placebo)
Time frame: Day 2 and Day 9
Body sway area: Area of the 95% confidence ellipse enclosing the center of pressure (A95) (MK-4305 versus placebo)
Time frame: Day 2 and Day 9
Number of participants with adverse events
Time frame: Up to 14 days after last dose
Number of participants discontinued from study due to adverse events
Time frame: Up to 14 days after last 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 22 Feb 2016.
- Background: PubMed 26039969Vermeeren A, Sun H, Vuurman EF, Jongen S, Van Leeuwen CJ, Van Oers AC, Palcza J, Li X, Laethem T, Heirman I, Bautmans A, Troyer MD, Wrishko R, McCrea J. On-the-Road Driving Performance the Morning after Bedtime Use of Suvorexant 20 and 40 mg: A Study in Non-Elderly Healthy Volunteers. Sleep. 2015 Nov 1;38(11):1803-13. doi: 10.5665/sleep.5168.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-4305 40 mg, MK-4305 20 mg and Zopiclone in people with Insomnia, run by Merck Sharp & Dohme LLC at 1 site in Netherlands.
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 7 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 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01311882, which also lists 1 linked publication.
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 22 Feb 2016; AzTrials last refreshed its copy on 6 Nov 2026.