PolysomnographyPhase 1NCT02549027
A Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG) (MK-1064-003)
A Phase 1 study testing MK-1064 and MK-6096 in people with Polysomnography, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this randomized, double-blind, placebo-controlled, 5-period crossover study is to assess the effect of single oral doses of MK-1064 on latency to persistent sleep (LPS) as measured by polysomnography (PSG) in healthy young male participants, and to evaluate the safety and tolerability of single oral… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Polysomnography
- What is being tested?
- MK-1064 and MK-6096
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 6 Nov 2009to 6 Apr 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) ≤31 kg/m^2
- In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
- Nonsmoker and has not used nicotine or nicotine-containing products for at least 6 months
- No history of any sleep disorder
- Has not used prescription or over the counter sedation or alerting medication in 4 weeks prior to screening
- Participant has a usual bedtime between 8:00 PM and 12:00 AM
- Participant has total sleep duration of ≥6.5 and ≤9 hours during the 4 weeks prior to screening
- Male participants with female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
Who cannot join
- Mentally or legally incapacitated, significant emotional problems at screening or expected during the conduct of the study or history of a clinically significant psychiatric disorder within the last 10 years
- History of any persistent sleep abnormality (including difficulty falling asleep, difficulty staying asleep) lasting for 3 months or more, or history of obstructive sleep apnea, restless leg syndrome, or narcolepsy
- History of clinically significant sleep disorders within the last 5 years
- History of circadian rhythm sleep disorder, clinically important parasomnia, or primary insomnia
- History of repeated falls or fractures secondary to falling within the past 2 years
- Participant works a night shift and is not able to avoid night shift work a minimum of 1 week prior to screening and for the duration of the study
Show all 18Show fewer
- Participant has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study
- Is a regular user of sedative-hypnotic agents
- History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- History of stroke, peripheral neuropathy, chronic seizures or other clinically significant neurological disorder or cognitive impairment
- History of cancer
- History of cataplexy
- Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies, beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study
- Participant consumes >3 servings of alcohol a day
- Participant consumes >6 caffeine servings a day
- Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to screening, or participated in another investigational study within 3 months prior to first dose of study drug
- History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
- Is currently a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within 2 years of screening
About this study
Official title: A Crossover Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG)
The purpose of this randomized, double-blind, placebo-controlled, 5-period crossover study is to assess the effect of single oral doses of MK-1064 on latency to persistent sleep (LPS) as measured by polysomnography (PSG) in healthy young male participants, and to evaluate the safety and tolerability of single oral doses of MK-1064 and MK-6096 in healthy young male participants. The primary efficacy hypothesis is that at least one dose of MK-1064 is superior to placebo in decreasing LPS in healthy male participants as assessed by PSG.
- Conditions
- Polysomnography
- Being tested
- MK-1064, MK-6096, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1064Drug
Oral MK-1064 tablets (10 and 50 mg strengths)
MK-6096Drug
Oral MK-6096 tablets (5 mg strength)
PlaceboDrug
Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)
| Study group | Role | What they receive |
|---|---|---|
| Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg | Experimental | For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 50 mg MK-1064, Period 2 - single dose of 250 mg MK-1064, Period 3 - single dose of placebo, Period 4 - single dose of 120 mg MK-1064. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses. Receives: Drug: MK-1064; Drug: MK-6096; Drug: Placebo |
| Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg | Experimental | For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of placebo, Period 2 - single dose of 50 mg MK-1064, Period 3 - single dose of 120 mg MK-1064, Period 4 - single dose of 250 mg MK-1064. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses. Receives: Drug: MK-1064; Drug: MK-6096; Drug: Placebo |
| Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg | Experimental | For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 120 mg MK-1064, Period 2 - single dose of placebo, Period 3 - single dose of 250 mg MK-1064, Period 4 - single dose of 50 mg MK-1064. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses. Receives: Drug: MK-1064; Drug: MK-6096; Drug: Placebo |
| Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo | Experimental | For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 250 mg MK-1064, Period 2 - single dose of 120 mg MK-1064, Period 3 - single dose of 50 mg MK-1064, Period 4 - single dose of placebo. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses. Receives: Drug: MK-1064; Drug: MK-6096; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency to Persistent Sleep (LPS) Following Single Doses of MK-1064 and Placebo
LPS is measured during overnight sleep laboratory (polysomnography [PSG]) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.
Measured: 1 to 9 hours post dose, within each treatment period
LPS Following Single Doses of MK-6096 and Placebo
LPS is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.
Measured: 1 to 9 hours post dose, within each treatment period
Number of Participants With Adverse Events (AEs)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.
Measured: Up to 14 days after the last dose of study drug (Up to approximately 42 days)
Number of Participants Who Discontinued Study Due to an AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.
Measured: Up to 14 days after the last dose of study drug (Up to approximately 42 days)
Secondary outcomes (4)
Wake Time After Sleep Onset (WASO) Following Single Doses of MK-1064 and Placebo
WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.
Measured: 1 to 9 hours post dose, within each treatment period
WASO Following Single Doses of MK-6096 and Placebo
WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.
Measured: 1 to 9 hours post dose, within each treatment period
Change From Baseline in Choice Reaction Time (CRT) Following Single Doses of MK-1064 and Placebo
CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word "NO" or the word "YES" is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time.
Measured: Pre-dose and 10 hours post dose, within each treatment period
Change From Baseline in CRT Following Single Doses of MK-6096 and Placebo
CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word "NO" or the word "YES" is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time.
Measured: Pre-dose and 10 hours post dose, within each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study start6 Nov 2009
- Primary completion6 Apr 2010
- Study completion6 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PolysomnographyStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549027
- Sponsor's protocol ID
- 1064-003
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2015
- Last updated
- 23 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG)
- ClinicalTrials.gov ID
- NCT02549027
- Acronym / sponsor ID
- 1064-003
- Conditions
- Polysomnography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2009 (actual)
- Primary completion
- 6 Apr 2010 (actual)
- Study completion
- 6 Apr 2010 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Posted 10 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized, double-blind, placebo-controlled, 5-period crossover study is to assess the effect of single oral doses of MK-1064 on latency to persistent sleep (LPS) as measured by polysomnography (PSG) in healthy young male participants, and to evaluate the safety and tolerability of single oral doses of MK-1064 and MK-6096 in healthy young male participants. The primary efficacy hypothesis is that at least one dose of MK-1064 is superior to placebo in decreasing LPS in healthy male participants as assessed by PSG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg | Experimental | Drug: MK-1064, Drug: MK-6096, Drug: PlaceboFor overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 50 mg MK-1064, Period 2 - single dose of 250 mg MK-1064, Period 3 - single dose of placebo, Period 4 - single dose of 120 mg MK-1064. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses. |
| Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg | Experimental | Drug: MK-1064, Drug: MK-6096, Drug: PlaceboFor overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of placebo, Period 2 - single dose of 50 mg MK-1064, Period 3 - single dose of 120 mg MK-1064, Period 4 - single dose of 250 mg MK-1064. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses. |
| Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg | Experimental | Drug: MK-1064, Drug: MK-6096, Drug: PlaceboFor overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 120 mg MK-1064, Period 2 - single dose of placebo, Period 3 - single dose of 250 mg MK-1064, Period 4 - single dose of 50 mg MK-1064. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses. |
| Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo | Experimental | Drug: MK-1064, Drug: MK-6096, Drug: PlaceboFor overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 250 mg MK-1064, Period 2 - single dose of 120 mg MK-1064, Period 3 - single dose of 50 mg MK-1064, Period 4 - single dose of placebo. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Body Mass Index (BMI) ≤31 kg/m^2
- In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
- Nonsmoker and has not used nicotine or nicotine-containing products for at least 6 months
- No history of any sleep disorder
- Has not used prescription or over the counter sedation or alerting medication in 4 weeks prior to screening
Key exclusion criteria (18 listed)
- Mentally or legally incapacitated, significant emotional problems at screening or expected during the conduct of the study or history of a clinically significant psychiatric disorder within the last 10 years
- History of any persistent sleep abnormality (including difficulty falling asleep, difficulty staying asleep) lasting for 3 months or more, or history of obstructive sleep apnea, restless leg syndrome, or narcolepsy
- History of clinically significant sleep disorders within the last 5 years
- History of circadian rhythm sleep disorder, clinically important parasomnia, or primary insomnia
- History of repeated falls or fractures secondary to falling within the past 2 years
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-1064Oral MK-1064 tablets (10 and 50 mg strengths) | Drug | Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg, Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo, Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg, Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg |
| MK-6096Oral MK-6096 tablets (5 mg strength) | Drug | Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg, Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo, Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg, Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg |
| PlaceboOral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets) | Drug | Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg, Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo, Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg, Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg |
Primary outcome
Latency to Persistent Sleep (LPS) Following Single Doses of MK-1064 and Placebo
Time frame: 1 to 9 hours post dose, within each treatment period
LPS is measured during overnight sleep laboratory (polysomnography [PSG]) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.
LPS Following Single Doses of MK-6096 and Placebo
Time frame: 1 to 9 hours post dose, within each treatment period
LPS is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.
Number of Participants With Adverse Events (AEs)
Time frame: Up to 14 days after the last dose of study drug (Up to approximately 42 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.
Number of Participants Who Discontinued Study Due to an AE
Time frame: Up to 14 days after the last dose of study drug (Up to approximately 42 days)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.
4 secondary outcomes
Wake Time After Sleep Onset (WASO) Following Single Doses of MK-1064 and Placebo
Time frame: 1 to 9 hours post dose, within each treatment period
WASO Following Single Doses of MK-6096 and Placebo
Time frame: 1 to 9 hours post dose, within each treatment period
Change From Baseline in Choice Reaction Time (CRT) Following Single Doses of MK-1064 and Placebo
Time frame: Pre-dose and 10 hours post dose, within each treatment period
Change From Baseline in CRT Following Single Doses of MK-6096 and Placebo
Time frame: Pre-dose and 10 hours post dose, within each treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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 Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-1064 and MK-6096 in people with Polysomnography, 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 8 inclusion and 18 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 23 Oct 2018. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Latency to Persistent Sleep (LPS) Following Single Doses of MK-1064 and Placebo (time frame: 1 to 9 hours post dose, within each treatment period). The study lists 4 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 23 Oct 2018.