HealthyPhase 1NCT06665230
A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005)
A Phase 1 study testing MK-6552 and Modafinil in people with Healthy and Narcolepsy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of this study is to learn what happens to MK-6552 in a person's body over time. Researchers will compare what happens to levels of MK-6552 in people's blood when it is taken with and without modafinil. 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
- Healthy, Narcolepsy
- What is being tested?
- MK-6552 and Modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 20 Nov 2023
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Is in good health based on medical history and physical examination
- Has a body mass index ≥18 and ≤32 kg/m^2, inclusive
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Alliance for Multispecialty Research, LLC (Site 0001)
Knoxville, Tennessee, 37920
About this study
Official title: A Three-Period Study to Evaluate the Effects of Modafinil on the Single-Dose Pharmacokinetics of MK-6552 in Healthy Male Participants
The goal of this study is to learn what happens to MK-6552 in a person's body over time. Researchers will compare what happens to levels of MK-6552 in people's blood when it is taken with and without modafinil. Researchers also want to learn about the safety of MK-6552 taken with and without modafinil and if people tolerate it.
- Conditions
- Healthy, Narcolepsy
- Being tested
- MK-6552, Modafinil
- 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
Oral administration
ModafinilDrug
Also called Provigil®
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| MK-6552 + Modafinil | Experimental | In Period 1, participants receive MK-6552 orally. In Period 2, participants receive MK-6552 orally plus low dose modafinil orally. In Period 3, participants receive MK-6552 orally plus high dose modafinil orally. Receives: Drug: MK-6552; Drug: Modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 1 month
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 19 days
High Dose Modafinil Effect: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552
Blood samples will be collected to determine the AUC0-inf of MK-6552 in the presence of high dose modafinil.
Measured: At designated timepoints (up to approximately 36 hours postdose)
High Dose Modafinil Effect: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6552
Blood samples will be collected to determine the AUC0-24hrs of MK-6552 in the presence of high dose modafinil.
Measured: At designated timepoints (up to approximately 24 hours postdose)
High Dose Modafinil Effect: Time to Maximum Plasma Concentration (Tmax) of MK-6552
Blood samples will be collected to determine the Tmax of MK-6552 in the presence of high dose modafinil.
Measured: At designated timepoints (up to approximately 36 hours postdose)
High Dose Modafinil Effect: Maximum Plasma Concentration (Cmax) of MK-6552
Blood samples will be collected to determine the Cmax of MK-6552 in the presence of high dose modafinil.
Measured: At designated timepoints (up to approximately 36 hours postdose)
High Dose Modafinil Effect: Plasma Concentration of MK-6552 at 6 Hours Postdose (C6hrs)
Blood samples will be collected to determine the C6hrs of MK-6552 in the presence of high dose modafinil.
Measured: At designated timepoints (up to approximately 6 hours postdose)
High Dose Modafinil Effect: Plasma Concentration of MK-6552 at 8 Hours Postdose (C8hrs)
Blood samples will be collected to determine the C8hrs of MK-6552 in the presence of high dose modafinil
Measured: At designated timepoints (up to approximately 8 hours postdose)
High Dose Modafinil Effect: Apparent Clearance (CL/F) of MK-6552
Blood samples will be collected to determine the CL/F of MK-6552 in the presence of high dose modafinil.
Measured: At designated timepoints (up to approximately 36 hours postdose)
High Dose Modafinil Effect: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-6552
Blood samples will be collected to determine the Vz/F of MK-6552 in the presence of high dose modafinil.
Measured: At designated timepoints (up to approximately 36 hours postdose)
High Dose Modafinil Effect: Apparent Terminal Half-life (t1/2) of MK-6552
Blood samples will be collected to determine the t1/2 of MK-6552 in the presence of high dose modafinil.
Measured: At designated timepoints (up to approximately 36 hours postdose)
Secondary outcomes (9)
Low Dose Modafinil Effect: AUC0-inf of MK-6552
Blood samples will be collected to determine the AUC0-inf of MK-6552 in the presence of low dose modafinil.
Measured: At designated timepoints (up to approximately 36 hours postdose)
Low Dose Modafinil Effect: AUC0-24hrs of MK-6552
Blood samples will be collected to determine the AUC0-24hrs of MK-6552 in the presence of low dose modafinil.
Measured: At designated timepoints (up to approximately 24 hours postdose)
Low Dose Modafinil Effect: Tmax of MK-6552
Blood samples will be collected to determine the Tmax of MK-6552 in the presence of low dose modafinil.
Measured: At designated timepoints (up to approximately 36 hours postdose)
Low Dose Modafinil Effect: Cmax of MK-6552
Blood samples will be collected to determine the Cmax of MK-6552 in the presence of low dose modafinil.
Measured: At designated timepoints (up to approximately 36 hours postdose)
Low Dose Modafinil Effect: C6hrs of MK-6552
Blood samples will be collected to determine the C6hrs of MK-6552 in the presence of low dose modafinil.
Measured: At designated timepoints (up to approximately 6 hours postdose)
Low Dose Modafinil Effect: C8hrs of MK-6552
Blood samples will be collected to determine the C8hrs of MK-6552 in the presence of low dose modafinil.
Measured: At designated timepoints (up to approximately 8 hours postdose)
Low Dose Modafinil Effect: CL/F of MK-6552
Blood samples will be collected to determine the CL/F of MK-6552 in the presence of low dose modafinil.
Measured: At designated timepoints (up to approximately 36 hours postdose)
Low Dose Modafinil Effect: Vz/F of MK-6552
Blood samples will be collected to determine the Vz/F of MK-6552 in the presence of low dose modafinil.
Measured: At designated timepoints (up to approximately 36 hours postdose)
Low Dose Modafinil Effect: t1/2 of MK-6552
Blood samples will be collected to determine the t1/2 of MK-6552 in the presence of low dose modafinil.
Measured: At designated timepoints (up to approximately 36 hours postdose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start20 Sep 2023
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT06665230
- Sponsor's protocol ID
- 6552-005
- Other IDs
- MK-6552-005
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 30 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 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Period Study to Evaluate the Effects of Modafinil on the Single-Dose Pharmacokinetics of MK-6552 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT06665230
- Acronym / sponsor ID
- 6552-005
- Conditions
- Healthy, Narcolepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 30 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.
The goal of this study is to learn what happens to MK-6552 in a person's body over time. Researchers will compare what happens to levels of MK-6552 in people's blood when it is taken with and without modafinil. Researchers also want to learn about the safety of MK-6552 taken with and without modafinil and if people tolerate it.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MK-6552 + Modafinil | Experimental | Drug: MK-6552, Drug: ModafinilIn Period 1, participants receive MK-6552 orally. In Period 2, participants receive MK-6552 orally plus low dose modafinil orally. In Period 3, participants receive MK-6552 orally plus high dose modafinil orally. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health based on medical history and physical examination
- Has a body mass index ≥18 and ≤32 kg/m^2, inclusive
Key exclusion criteria (3 listed)
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer
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-6552Oral administration | Drug | MK-6552 + Modafinil |
| ModafinilAlso: Provigil®Oral administration | Drug | MK-6552 + Modafinil |
Primary outcome
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 1 month
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 19 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
High Dose Modafinil Effect: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552
Time frame: At designated timepoints (up to approximately 36 hours postdose)
Blood samples will be collected to determine the AUC0-inf of MK-6552 in the presence of high dose modafinil.
High Dose Modafinil Effect: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6552
Time frame: At designated timepoints (up to approximately 24 hours postdose)
Blood samples will be collected to determine the AUC0-24hrs of MK-6552 in the presence of high dose modafinil.
High Dose Modafinil Effect: Time to Maximum Plasma Concentration (Tmax) of MK-6552
Time frame: At designated timepoints (up to approximately 36 hours postdose)
Blood samples will be collected to determine the Tmax of MK-6552 in the presence of high dose modafinil.
High Dose Modafinil Effect: Maximum Plasma Concentration (Cmax) of MK-6552
Time frame: At designated timepoints (up to approximately 36 hours postdose)
Blood samples will be collected to determine the Cmax of MK-6552 in the presence of high dose modafinil.
High Dose Modafinil Effect: Plasma Concentration of MK-6552 at 6 Hours Postdose (C6hrs)
Time frame: At designated timepoints (up to approximately 6 hours postdose)
Blood samples will be collected to determine the C6hrs of MK-6552 in the presence of high dose modafinil.
High Dose Modafinil Effect: Plasma Concentration of MK-6552 at 8 Hours Postdose (C8hrs)
Time frame: At designated timepoints (up to approximately 8 hours postdose)
Blood samples will be collected to determine the C8hrs of MK-6552 in the presence of high dose modafinil
High Dose Modafinil Effect: Apparent Clearance (CL/F) of MK-6552
Time frame: At designated timepoints (up to approximately 36 hours postdose)
Blood samples will be collected to determine the CL/F of MK-6552 in the presence of high dose modafinil.
High Dose Modafinil Effect: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-6552
Time frame: At designated timepoints (up to approximately 36 hours postdose)
Blood samples will be collected to determine the Vz/F of MK-6552 in the presence of high dose modafinil.
High Dose Modafinil Effect: Apparent Terminal Half-life (t1/2) of MK-6552
Time frame: At designated timepoints (up to approximately 36 hours postdose)
Blood samples will be collected to determine the t1/2 of MK-6552 in the presence of high dose modafinil.
9 secondary outcomes
Low Dose Modafinil Effect: AUC0-inf of MK-6552
Time frame: At designated timepoints (up to approximately 36 hours postdose)
Low Dose Modafinil Effect: AUC0-24hrs of MK-6552
Time frame: At designated timepoints (up to approximately 24 hours postdose)
Low Dose Modafinil Effect: Tmax of MK-6552
Time frame: At designated timepoints (up to approximately 36 hours postdose)
Low Dose Modafinil Effect: Cmax of MK-6552
Time frame: At designated timepoints (up to approximately 36 hours postdose)
Low Dose Modafinil Effect: C6hrs of MK-6552
Time frame: At designated timepoints (up to approximately 6 hours postdose)
Low Dose Modafinil Effect: C8hrs of MK-6552
Time frame: At designated timepoints (up to approximately 8 hours postdose)
Low Dose Modafinil Effect: CL/F of MK-6552
Time frame: At designated timepoints (up to approximately 36 hours postdose)
Low Dose Modafinil Effect: Vz/F of MK-6552
Time frame: At designated timepoints (up to approximately 36 hours postdose)
Low Dose Modafinil Effect: t1/2 of MK-6552
Time frame: At designated timepoints (up to approximately 36 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 30 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
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-6552 and Modafinil in people with Healthy and Narcolepsy, run by Merck Sharp & Dohme LLC at 1 site 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 30 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 1 site 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?
Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 1 month). The study lists 11 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 30 Oct 2024.