HealthyPhase 1NCT06662396
A Study of Diltiazem With a Single Dose of MK-6552 in Healthy Adult Participants (MK-6552-007)
A Phase 1 study testing MK-6552 and Diltiazem in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The main goal of this study is to learn what happens to MK-6552 in a person's body over time (a pharmacokinetic or PK study). Researchers want to know what happens to MK-6552 in healthy adults when a single dose of MK-6552 is given with multiple doses of diltiazem. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-6552 and Diltiazem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2024to 27 Sep 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
- The main inclusion criteria include but are not limited to the following:
- Is in good health before randomization
- Body Mass Index (BMI) between 18 and 32 kg/m^2, inclusive
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- History of cancer (malignancy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Effects of Coadministration of Diltiazem on the Plasma Pharmacokinetics of a Single Dose of MK-6552 in Healthy Participants
The main goal of this study is to learn what happens to MK-6552 in a person's body over time (a pharmacokinetic or PK study). Researchers want to know what happens to MK-6552 in healthy adults when a single dose of MK-6552 is given with multiple doses of diltiazem. The researchers believe that multiple doses of diltiazem will not affect the highest amount of MK-6552 in the blood.
- Conditions
- Healthy
- Being tested
- MK-6552, Diltiazem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-6552Drug
Oral Gelatin Coated Capsule
DiltiazemDrug
Oral Extended-Release Capsule
| Study group | Role | What they receive |
|---|---|---|
| MK-6552 + Diltiazem | Experimental | Participants receive a single dose of MK-6552 on Period 1 Day 1. Participants receive a Diltiazem every day (QD) for 6 days (Period 2 Days 1-6). On Period 2 Day 2 participants receive a single dose of MK-6552. Receives: Drug: MK-6552; Drug: Diltiazem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of MK-6552
Blood samples will be collected to determine the Cmax of MK-6552 in plasma.
Measured: Pre-dose and at designated time points up to 24 hours post dose
Secondary outcomes (10)
Number of Participants Who Experience and Adverse Event (AEs)
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 20 days
Number of Participants Who Discontinue Study 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 20 days
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 plasma.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of MK-6552
Blood samples will be collected to determine the AUC0-24 of MK-6552 in plasma.
Measured: Pre-dose and at designated time points up to 24 hours post dose
Time to Maximum Plasma Concentration (Tmax) of MK-6552
Blood samples will be collected to determine the Tmax of MK-6552 in plasma.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Concentration of MK-6552 at 6 Hours Postdose (C6h)
Blood samples will be collected to determine the C6h of MK-6552 in plasma.
Measured: Pre-dose and at designated time points up to 6 hours post dose
Concentration of MK-6552 at 8 Hours Postdose (C8h)
Blood samples will be collected to determine the C8h of MK-6552 in plasma.
Measured: Pre-dose and at designated time points up to 8 hours post dose
Apparent Clearance (CL/F) of MK-6552
Blood samples will be collected to determine the CL/F of MK-6552 in plasma.
Measured: Pre-dose and at designated time points up to 96 hours post dose
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 plasma.
Measured: Pre-dose and at designated time points up to 96 hours post dose
Apparent Terminal Half-Life (t1/2) of MK-6552
Blood samples will be collected to determine the t1/2 of MK-6552 in plasma.
Measured: Pre-dose and at designated time points up to 96 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 posted28 Oct 2024
- Study start13 Jun 2024
- Primary completion27 Sep 2024
- Study completion27 Sep 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT06662396
- Sponsor's protocol ID
- 6552-007
- Other IDs
- MK-6552-007
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 28 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 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effects of Coadministration of Diltiazem on the Plasma Pharmacokinetics of a Single Dose of MK-6552 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06662396
- Acronym / sponsor ID
- 6552-007
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 28 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 main goal of this study is to learn what happens to MK-6552 in a person's body over time (a pharmacokinetic or PK study). Researchers want to know what happens to MK-6552 in healthy adults when a single dose of MK-6552 is given with multiple doses of diltiazem. The researchers believe that multiple doses of diltiazem will not affect the highest amount of MK-6552 in the blood.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MK-6552 + Diltiazem | Experimental | Drug: MK-6552, Drug: DiltiazemParticipants receive a single dose of MK-6552 on Period 1 Day 1. Participants receive a Diltiazem every day (QD) for 6 days (Period 2 Days 1-6). On Period 2 Day 2 participants receive a single dose of MK-6552. |
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 before randomization
- Body Mass Index (BMI) between 18 and 32 kg/m^2, inclusive
Key exclusion criteria (3 listed)
- History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- History of cancer (malignancy)
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 Gelatin Coated Capsule | Drug | MK-6552 + Diltiazem |
| DiltiazemOral Extended-Release Capsule | Drug | MK-6552 + Diltiazem |
Primary outcome
Maximum Plasma Concentration (Cmax) of MK-6552
Time frame: Pre-dose and at designated time points up to 24 hours post dose
Blood samples will be collected to determine the Cmax of MK-6552 in plasma.
10 secondary outcomes
Number of Participants Who Experience and Adverse Event (AEs)
Time frame: Up to approximately 20 days
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to approximately 20 days
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of MK-6552
Time frame: Pre-dose and at designated time points up to 24 hours post dose
Time to Maximum Plasma Concentration (Tmax) of MK-6552
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Concentration of MK-6552 at 6 Hours Postdose (C6h)
Time frame: Pre-dose and at designated time points up to 6 hours post dose
Concentration of MK-6552 at 8 Hours Postdose (C8h)
Time frame: Pre-dose and at designated time points up to 8 hours post dose
Apparent Clearance (CL/F) of MK-6552
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-6552
Time frame: Pre-dose and at designated time points up to 96 hours post dose
Apparent Terminal Half-Life (t1/2) of MK-6552
Time frame: Pre-dose and at designated time points up to 96 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 28 Oct 2024.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/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
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 Diltiazem in people with Healthy, 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 28 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?
Maximum Plasma Concentration (Cmax) of MK-6552 (time frame: Pre-dose and at designated time points up to 24 hours post dose). 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 28 Oct 2024.