HealthyPhase 1NCT06703463
A Drug-Drug Interaction Study of Diltiazem and MK-1167 in Healthy Adult Participants (MK-1167-006)
A Phase 1 study testing MK-1167 and Diltiazem in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of this study this study is to learn about the safety of MK-1167 and if people tolerate it. Researchers will compare what happens to MK-1167 in the body when it is given with and without another medicine called diltiazem. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MK-1167 and Diltiazem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2023to 2 Feb 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 19 to 50 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:
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting
- Body mass index (BMI) ≥18.0 and ≤32.0 kg/m^2
- Able to swallow multiple capsules
- In good health
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- History or presence of second- or third-degree atrioventricular heart block (except in participants with a functional artificial pacemaker)
- History or presence of clinically significant sick sinus syndrome
- History of cancer (malignancy) within the past 5 years
- Unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Diltiazem on the Single-Dose Pharmacokinetics of MK-1167 in Healthy Adult Participants
The goal of this study this study is to learn about the safety of MK-1167 and if people tolerate it. Researchers will compare what happens to MK-1167 in the body when it is given with and without another medicine called diltiazem.
- Conditions
- Healthy
- Being tested
- MK-1167, Diltiazem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1167Drug
Administered via oral capsule per dosing regimen.
DiltiazemDrug
Diltiazem hydrochloride administered at a dose of 240 mg QD via oral capsules.
| Study group | Role | What they receive |
|---|---|---|
| MK-1167 Period 1 | Experimental | On Day 1 a single dose of MK-1167 will be administered. Receives: Drug: MK-1167 |
| MK-1167 Period 2 | Experimental | There will be a washout of at least 35 days between MK-1167 dosing in Period 1 and the first diltiazem dose in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 49 consecutive days with a single dose of MK-1167 coadministered on Day 3. Receives: Drug: MK-1167; Drug: Diltiazem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience one or more adverse events (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 99 days
Number of participants who discontinue study intervention 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 85 days
Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-1167 in plasma
AUC0-inf of MK-1167 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 50 days post-dose
Secondary outcomes (7)
Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-1167 in plasma
AUC0-last of MK-1167 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 50 days post-dose
Maximum concentration (Cmax) of MK-1167 in plasma
Cmax of MK-1167 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 50 days post-dose
Concentration at hour 24 (C24) of MK-1167 in plasma
C24 of MK-1167 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 24 hours post-dose
Time to maximum concentration (Tmax) of MK-1167 in plasma
Tmax of MK-1167 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 50 days post-dose
Apparent terminal half-life (t1/2) of MK-1167 in plasma
t1/2 of MK-1167 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 50 days post-dose
Apparent clearance (CL/F) of MK-1167 in plasma
CL/F of MK-1167 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 50 days post-dose
Apparent volume of distribution during terminal phase (Vz/F) of MK-1167 in plasma
Vz/F of MK-1167 in plasma will be determined.
Measured: Predose, and at designated timepoints up to 50 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start17 Oct 2023
- Primary completion2 Feb 2024
- Study completion2 Feb 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT06703463
- Sponsor's protocol ID
- 1167-006
- Other IDs
- MK-1167-006
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 25 Nov 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 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Diltiazem on the Single-Dose Pharmacokinetics of MK-1167 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06703463
- Acronym / sponsor ID
- 1167-006
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 25 Nov 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 this study is to learn about the safety of MK-1167 and if people tolerate it. Researchers will compare what happens to MK-1167 in the body when it is given with and without another medicine called diltiazem.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-1167 Period 1 | Experimental | Drug: MK-1167On Day 1 a single dose of MK-1167 will be administered. |
| MK-1167 Period 2 | Experimental | Drug: MK-1167, Drug: DiltiazemThere will be a washout of at least 35 days between MK-1167 dosing in Period 1 and the first diltiazem dose in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 49 consecutive days with a single dose of MK-1167 coadministered on Day 3. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting
- Body mass index (BMI) ≥18.0 and ≤32.0 kg/m^2
- Able to swallow multiple capsules
- In good health
Key exclusion criteria (5 listed)
- History or presence of second- or third-degree atrioventricular heart block (except in participants with a functional artificial pacemaker)
- History or presence of clinically significant sick sinus syndrome
- History of cancer (malignancy) within the past 5 years
- Unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing
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-1167Administered via oral capsule per dosing regimen. | Drug | MK-1167 Period 1, MK-1167 Period 2 |
| DiltiazemDiltiazem hydrochloride administered at a dose of 240 mg QD via oral capsules. | Drug | MK-1167 Period 2 |
Primary outcome
Number of participants who experience one or more adverse events (AEs)
Time frame: Up to approximately 99 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.
Number of participants who discontinue study intervention due to an AE
Time frame: Up to approximately 85 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.
Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-1167 in plasma
Time frame: Predose, and at designated timepoints up to 50 days post-dose
AUC0-inf of MK-1167 in plasma will be determined.
7 secondary outcomes
Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-1167 in plasma
Time frame: Predose, and at designated timepoints up to 50 days post-dose
Maximum concentration (Cmax) of MK-1167 in plasma
Time frame: Predose, and at designated timepoints up to 50 days post-dose
Concentration at hour 24 (C24) of MK-1167 in plasma
Time frame: Predose, and at designated timepoints up to 24 hours post-dose
Time to maximum concentration (Tmax) of MK-1167 in plasma
Time frame: Predose, and at designated timepoints up to 50 days post-dose
Apparent terminal half-life (t1/2) of MK-1167 in plasma
Time frame: Predose, and at designated timepoints up to 50 days post-dose
Apparent clearance (CL/F) of MK-1167 in plasma
Time frame: Predose, and at designated timepoints up to 50 days post-dose
Apparent volume of distribution during terminal phase (Vz/F) of MK-1167 in plasma
Time frame: Predose, and at designated timepoints up to 50 days 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 25 Nov 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-1167 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 5 inclusion and 5 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 25 Nov 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 one or more adverse events (AEs) (time frame: Up to approximately 99 days). 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 25 Nov 2024.