HealthyPhase 1NCT06772779
A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026)
A Phase 1 study testing Warfarin, Enlicitide Decanoate and Lisinopril 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 in a person's body over time when they take enlicitide decanoate with warfarin or lisinopril. Researchers want to learn if the amount of warfarin in a person's blood is similar when warfarin is taken alone or with enlicitide decanoate. 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?
- Warfarin, Enlicitide Decanoate and Lisinopril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 4 Jun 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 key inclusion criteria include but are not limited to:
- Is in good health
- Has a body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
Who cannot join
- The key exclusion criteria include but are not limited to:
- History of gastrointestinal disease which may affect food or drug absorption, or has had a gastric bypass or similar surgery
- History of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Effect of MK-0616 on Warfarin and Lisinopril Pharmacokinetics in Healthy Adult Participants
The main goal of this study is to learn what happens in a person's body over time when they take enlicitide decanoate with warfarin or lisinopril. Researchers want to learn if the amount of warfarin in a person's blood is similar when warfarin is taken alone or with enlicitide decanoate.
Enlicitide decanoate is a new medicine that lowers the amount of cholesterol in a person's blood. Warfarin is a drug that reduces risk of blood clotting, and lisinopril is a drug that lowers blood pressure.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Also called Jantoven
single oral dose
Enlicitide DecanoateDrug
Also called MK-0616
single oral dose
LisinoprilDrug
Also called Zestril
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Warfarin Plus Enlicitide Decanoate | Experimental | Participants receive oral warfarin and oral enlicitide decanoate. Receives: Drug: Warfarin; Drug: Enlicitide Decanoate |
| Lisinopril Plus Enlicitide Decanoate | Experimental | Participants receive oral lisinopril and oral enlicitide decanoate. Receives: Drug: Enlicitide Decanoate; Drug: Lisinopril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Warfarin
Blood samples will be collected to determine the AUC0-Inf of warfarin.
Measured: At designated timepoints (up to approximately 2 weeks postdose)
Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of Warfarin
Blood samples will be collected to determine the AUC0-Last of warfarin.
Measured: At designated timepoints (up to approximately 2 weeks postdose)
Maximum Plasma Concentration (Cmax) of Warfarin
Blood samples will be collected to determine the Cmax of warfarin.
Measured: At designated timepoints (up to approximately 2 weeks postdose)
Time to Maximum Plasma Concentration (Tmax) of Warfarin
Blood samples will be collected to determine the Tmax of warfarin.
Measured: At designated timepoints (up to approximately 2 weeks postdose)
Apparent Terminal Half-life (t½) of Warfarin
Blood samples will be collected to determine the t½ of warfarin.
Measured: At designated timepoints (up to approximately 2 weeks postdose)
Apparent Clearance (CL/F) of Warfarin
Blood samples will be collected to determine the CL/F of warfarin.
Measured: At designated timepoints (up to approximately 2 weeks postdose)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Warfarin
Blood samples will be collected to determine the Vz/F of warfarin.
Measured: At designated timepoints (up to approximately 2 weeks postdose)
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Lisinopril
Blood samples will be collected to determine the AUC0-Inf of lisinopril.
Measured: At designated timepoints (up to approximately 3 days postdose)
Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of Lisinopril
Blood samples will be collected to determine the AUC0-Last of lisinopril.
Measured: At designated timepoints (up to approximately 3 days postdose)
Maximum Plasma Concentration (Cmax) of Lisinopril
Blood samples will be collected to determine the Cmax of lisinopril.
Measured: At designated timepoints (up to approximately 3 days postdose)
Time to Maximum Plasma Concentration (Tmax) of Lisinopril
Blood samples will be collected to determine the Tmax of lisinopril.
Measured: At designated timepoints (up to approximately 3 days postdose)
Apparent Terminal Half-life (t½) of Lisinopril
Blood samples will be collected to determine the t½ of lisinopril.
Measured: At designated timepoints (up to approximately 3 days postdose)
Apparent Clearance (CL/F) of Lisinopril
Blood samples will be collected to determine the CL/F of lisinopril.
Measured: At designated timepoints (up to approximately 3 days postdose)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Lisinopril
Blood samples will be collected to determine the Vz/F of lisinopril.
Measured: At designated timepoints (up to approximately 3 days postdose)
Secondary outcomes (4)
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) in Part 1
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration. The number of participants who experience a TEAE in Part 1 will be reported.
Measured: Up to approximately 5 weeks
Number of Participants Who Discontinue Study due to a TEAE in Part 1
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration. The number of participants who discontinue study due to a TEAE in Part 1 will be reported.
Measured: Up to approximately 5 weeks
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) in Part 2
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration. The number of participants who experience a TEAE in Part 2 will be reported.
Measured: Up to approximately 28 days
Number of Participants Who Discontinue Study due to a TEAE in Part 2
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration. The number of participants who discontinue study due to a TEAE in Part 2 will be reported.
Measured: Up to approximately 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Apr 2024
- Primary completion4 Jun 2024
- Study completion4 Jun 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
- None (open label)
- Enrolment
- 36 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
- NCT06772779
- Sponsor's protocol ID
- 0616-026
- Other IDs
- MK-0616-026
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 15 Jan 2025
- 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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Effect of MK-0616 on Warfarin and Lisinopril Pharmacokinetics in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06772779
- Acronym / sponsor ID
- 0616-026
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 14 Jan 2025 (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 in a person's body over time when they take enlicitide decanoate with warfarin or lisinopril. Researchers want to learn if the amount of warfarin in a person's blood is similar when warfarin is taken alone or with enlicitide decanoate.
Enlicitide decanoate is a new medicine that lowers the amount of cholesterol in a person's blood. Warfarin is a drug that reduces risk of blood clotting, and lisinopril is a drug that lowers blood pressure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warfarin Plus Enlicitide Decanoate | Experimental | Drug: Warfarin, Drug: Enlicitide DecanoateParticipants receive oral warfarin and oral enlicitide decanoate. |
| Lisinopril Plus Enlicitide Decanoate | Experimental | Drug: Enlicitide Decanoate, Drug: LisinoprilParticipants receive oral lisinopril and oral enlicitide decanoate. |
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
- Has a body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
Key exclusion criteria (3 listed)
- History of gastrointestinal disease which may affect food or drug absorption, or has had a gastric bypass or similar surgery
- 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 |
|---|---|---|
| WarfarinAlso: Jantovensingle oral dose | Drug | Warfarin Plus Enlicitide Decanoate |
| Enlicitide DecanoateAlso: MK-0616single oral dose | Drug | Lisinopril Plus Enlicitide Decanoate, Warfarin Plus Enlicitide Decanoate |
| LisinoprilAlso: Zestrilsingle oral dose | Drug | Lisinopril Plus Enlicitide Decanoate |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Warfarin
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the AUC0-Inf of warfarin.
Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of Warfarin
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the AUC0-Last of warfarin.
Maximum Plasma Concentration (Cmax) of Warfarin
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the Cmax of warfarin.
Time to Maximum Plasma Concentration (Tmax) of Warfarin
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the Tmax of warfarin.
Apparent Terminal Half-life (t½) of Warfarin
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the t½ of warfarin.
Apparent Clearance (CL/F) of Warfarin
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the CL/F of warfarin.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Warfarin
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the Vz/F of warfarin.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Lisinopril
Time frame: At designated timepoints (up to approximately 3 days postdose)
Blood samples will be collected to determine the AUC0-Inf of lisinopril.
Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of Lisinopril
Time frame: At designated timepoints (up to approximately 3 days postdose)
Blood samples will be collected to determine the AUC0-Last of lisinopril.
Maximum Plasma Concentration (Cmax) of Lisinopril
Time frame: At designated timepoints (up to approximately 3 days postdose)
Blood samples will be collected to determine the Cmax of lisinopril.
Time to Maximum Plasma Concentration (Tmax) of Lisinopril
Time frame: At designated timepoints (up to approximately 3 days postdose)
Blood samples will be collected to determine the Tmax of lisinopril.
Apparent Terminal Half-life (t½) of Lisinopril
Time frame: At designated timepoints (up to approximately 3 days postdose)
Blood samples will be collected to determine the t½ of lisinopril.
Apparent Clearance (CL/F) of Lisinopril
Time frame: At designated timepoints (up to approximately 3 days postdose)
Blood samples will be collected to determine the CL/F of lisinopril.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Lisinopril
Time frame: At designated timepoints (up to approximately 3 days postdose)
Blood samples will be collected to determine the Vz/F of lisinopril.
4 secondary outcomes
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) in Part 1
Time frame: Up to approximately 5 weeks
Number of Participants Who Discontinue Study due to a TEAE in Part 1
Time frame: Up to approximately 5 weeks
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) in Part 2
Time frame: Up to approximately 28 days
Number of Participants Who Discontinue Study due to a TEAE in Part 2
Time frame: Up to approximately 28 days
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 15 Jan 2025.
- 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 Warfarin, Enlicitide Decanoate and Lisinopril 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 15 Jan 2025. 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?
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Warfarin (time frame: At designated timepoints (up to approximately 2 weeks postdose)). The study lists 14 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 15 Jan 2025.