HealthyPhase 1NCT06619665
A Study of MK-6552 in Sleep Deprived Healthy Participants (MK-6552-003)
A Phase 1 study testing MK-6552 and Modafinil in people with Healthy and Narcolepsy, run by Merck Sharp & Dohme LLC at 2 sites in United States.
Trial summary
This study examined the safety of the drug MK-6552 and if people tolerated it. It also studied whether MK-6552 works better than placebo for staying awake in sleep deprived healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Narcolepsy
- What is being tested?
- MK-6552 and Modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Mar 2024to 16 Jul 2024
- 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
- Criteria include but are not limited to the following:
- Is in good health
- Body Mass Index (BMI) between 18 and 32 kg/m^2, inclusive.
Who cannot join
- Criteria include but are not limited to the following:
- History of or current hypertension,
- Has a history of sleep disorders:
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NeuroTrials Research Inc (Site 0001)
Atlanta, Georgia, 30328
Clinilabs (Site 0003)
Eatontown, New Jersey, 07724
About this study
Official title: A Randomized, Double-blind, 3-Period Crossover Study to Assess the Effects of MK-6552 on Sleep Latency in Sleep Deprived Healthy Participants With Modafinil as a Positive Control
This study examined the safety of the drug MK-6552 and if people tolerated it. It also studied whether MK-6552 works better than placebo for staying awake in sleep deprived healthy participants.
- Conditions
- Healthy, Narcolepsy
- Being tested
- MK-6552, MK-6552 placebo, Modafinil, Modafinil placebo
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-6552Drug
MK-6552 gelatin coated capsules taken orally two times 8 hours apart
MK-6552 placeboDrug
MK-6552 placebo gelatin coated capsules taken orally two times 8 hours apart
ModafinilDrug
Modafinil tablet taken once orally
Modafinil placeboDrug
Modafinil placebo tablet taken once orally
| Study group | Role | What they receive |
|---|---|---|
| MK-6552-Placebo-Modafinil | Experimental | Participants were treated in period 1 with MK-6552; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period. Receives: Drug: MK-6552; Drug: MK-6552 placebo; Drug: Modafinil; Drug: Modafinil placebo |
| MK-6552-Modafinil-Placebo | Experimental | Participants were treated in period 1 with MK-6552; in period 2 with Modafinil; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period. Receives: Drug: MK-6552; Drug: MK-6552 placebo; Drug: Modafinil; Drug: Modafinil placebo |
| Placebo-Modafinil-MK-6552 | Experimental | Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with Modafinil; and in period 3 with MK-6552; with a 7-day washout between each period. Receives: Drug: MK-6552; Drug: MK-6552 placebo; Drug: Modafinil; Drug: Modafinil placebo |
| Placebo-MK-6552-Modafinil | Experimental | Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period. Receives: Drug: MK-6552; Drug: MK-6552 placebo; Drug: Modafinil; Drug: Modafinil placebo |
| Modafinil-MK-6552-Plaebo | Experimental | Participants were treated in period 1 with Modafinil; in period 2 withMK-6552; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period. Receives: Drug: MK-6552; Drug: MK-6552 placebo; Drug: Modafinil; Drug: Modafinil placebo |
| Modafinil-Plaebo-MK-6552 | Experimental | Participants were treated in period 1 with Modafinil; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with MK-6552; with a 7-day washout between each period. Receives: Drug: MK-6552; Drug: MK-6552 placebo; Drug: Modafinil; Drug: Modafinil placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with an Adverse Event (AE)
Percentage of participants with at least one AE
Measured: Up to Day 30
Participants who discontinued from study due to an AE
Percentage of participants who discontinued from study due to an AE
Measured: Day 1
Maintenance of Wakefulness Test (MWT) for MK-6552
Sleep latency of MWT for MK-6552 compared with placebo
Measured: Postdose time to maximum plasma concentration (Tmax) (at designated timepoints up to 24 hours postdose)
Secondary outcomes (6)
Area under the concentration=time curve (AUC) for plasma MK-6552
AUC for plasma MK-6552 from 0-24 hours postdose
Measured: At designated timepoints up to 24 hours postdose
Concentration of plasma MK-6522 at Tmax following morning (AM) dose
Plasma concentration of MK-6552 at Tmax following AM dose
Measured: Tmax following AM dose (at designated timepoints up to 24 hours postdose)
Concentration of plasma MK-6522 at Tmax following afternoon (PM) dose
Plasma concentration of MK-6552 at Tmax following PM dose
Measured: Tmax following PM dose (at designated timepoints up to 24 hours postdose)
Concentration of plasma MK-6552 8 hours (C8h) after first dose
C8h of plasma MK-6552 after first dose
Measured: 8 hours
Concentration of plasma MK-6552 24 hours (C24h) after first dose
C24h of plasma MK-6552 after first dose
Measured: 24 hours
MWT for Modafinil
Sleep latency of MWT for Modafinil compared with placebo
Measured: 2 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start19 Mar 2024
- Primary completion16 Jul 2024
- Study completion16 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 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
- NCT06619665
- Sponsor's protocol ID
- 6552-003
- Other IDs
- MK-6552-003
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, 3-Period Crossover Study to Assess the Effects of MK-6552 on Sleep Latency in Sleep Deprived Healthy Participants With Modafinil as a Positive Control
- ClinicalTrials.gov ID
- NCT06619665
- Acronym / sponsor ID
- 6552-003
- Conditions
- Healthy, Narcolepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 1 Oct 2024 (actual)
- 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 examined the safety of the drug MK-6552 and if people tolerated it. It also studied whether MK-6552 works better than placebo for staying awake in sleep deprived healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MK-6552-Placebo-Modafinil | Experimental | Drug: MK-6552, Drug: MK-6552 placebo, Drug: Modafinil, Drug: Modafinil placeboParticipants were treated in period 1 with MK-6552; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period. |
| MK-6552-Modafinil-Placebo | Experimental | Drug: MK-6552, Drug: MK-6552 placebo, Drug: Modafinil, Drug: Modafinil placeboParticipants were treated in period 1 with MK-6552; in period 2 with Modafinil; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period. |
| Placebo-Modafinil-MK-6552 | Experimental | Drug: MK-6552, Drug: MK-6552 placebo, Drug: Modafinil, Drug: Modafinil placeboParticipants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with Modafinil; and in period 3 with MK-6552; with a 7-day washout between each period. |
| Placebo-MK-6552-Modafinil | Experimental | Drug: MK-6552, Drug: MK-6552 placebo, Drug: Modafinil, Drug: Modafinil placeboParticipants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period. |
| Modafinil-MK-6552-Plaebo | Experimental | Drug: MK-6552, Drug: MK-6552 placebo, Drug: Modafinil, Drug: Modafinil placeboParticipants were treated in period 1 with Modafinil; in period 2 withMK-6552; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period. |
| Modafinil-Plaebo-MK-6552 | Experimental | Drug: MK-6552, Drug: MK-6552 placebo, Drug: Modafinil, Drug: Modafinil placeboParticipants were treated in period 1 with Modafinil; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with MK-6552; with a 7-day washout between each period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health
- Body Mass Index (BMI) between 18 and 32 kg/m^2, inclusive.
Key exclusion criteria (3 listed)
- History of or current hypertension,
- Has a history of sleep disorders:
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-6552MK-6552 gelatin coated capsules taken orally two times 8 hours apart | Drug | MK-6552-Modafinil-Placebo, MK-6552-Placebo-Modafinil, Modafinil-MK-6552-Plaebo, Modafinil-Plaebo-MK-6552, Placebo-MK-6552-Modafinil, Placebo-Modafinil-MK-6552 |
| MK-6552 placeboMK-6552 placebo gelatin coated capsules taken orally two times 8 hours apart | Drug | MK-6552-Modafinil-Placebo, MK-6552-Placebo-Modafinil, Modafinil-MK-6552-Plaebo, Modafinil-Plaebo-MK-6552, Placebo-MK-6552-Modafinil, Placebo-Modafinil-MK-6552 |
| ModafinilModafinil tablet taken once orally | Drug | MK-6552-Modafinil-Placebo, MK-6552-Placebo-Modafinil, Modafinil-MK-6552-Plaebo, Modafinil-Plaebo-MK-6552, Placebo-MK-6552-Modafinil, Placebo-Modafinil-MK-6552 |
| Modafinil placeboModafinil placebo tablet taken once orally | Drug | MK-6552-Modafinil-Placebo, MK-6552-Placebo-Modafinil, Modafinil-MK-6552-Plaebo, Modafinil-Plaebo-MK-6552, Placebo-MK-6552-Modafinil, Placebo-Modafinil-MK-6552 |
Primary outcome
Participants with an Adverse Event (AE)
Time frame: Up to Day 30
Percentage of participants with at least one AE
Participants who discontinued from study due to an AE
Time frame: Day 1
Percentage of participants who discontinued from study due to an AE
Maintenance of Wakefulness Test (MWT) for MK-6552
Time frame: Postdose time to maximum plasma concentration (Tmax) (at designated timepoints up to 24 hours postdose)
Sleep latency of MWT for MK-6552 compared with placebo
6 secondary outcomes
Area under the concentration=time curve (AUC) for plasma MK-6552
Time frame: At designated timepoints up to 24 hours postdose
Concentration of plasma MK-6522 at Tmax following morning (AM) dose
Time frame: Tmax following AM dose (at designated timepoints up to 24 hours postdose)
Concentration of plasma MK-6522 at Tmax following afternoon (PM) dose
Time frame: Tmax following PM dose (at designated timepoints up to 24 hours postdose)
Concentration of plasma MK-6552 8 hours (C8h) after first dose
Time frame: 8 hours
Concentration of plasma MK-6552 24 hours (C24h) after first dose
Time frame: 24 hours
MWT for Modafinil
Time frame: 2 hours postdose
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 1 Oct 2024.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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
2 sites 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-6552 and Modafinil in people with Healthy and Narcolepsy, run by Merck Sharp & Dohme LLC at 2 sites in United States.
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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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?
Participants with an Adverse Event (AE) (time frame: Up to Day 30). The study lists 3 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 1 Oct 2024.