HealthyPhase 1NCT06658652
The Effect of Food and Water Volume in Healthy Adult Participants Administered Enlicitide Decanoate (MK-0616) (MK-0616-022)
A Phase 1 study testing Enlicitide decanoate in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
Enlicitide decanoate (MK-0616, the study medicine) is in a class of medicines that have been shown to reduce LDL-C. Enlicitide decanoate is different from the other medicines in this class because it is taken as a tablet and not an injection. 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?
- Enlicitide decanoate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2023to 26 Dec 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The key inclusion criteria include but are not limited to the following:
- Has body mass index (BMI) ≥18.0 and ≤32.0 kg/m^2
- Is medically healthy with no clinically significant medical history
Who cannot join
- The key exclusion criteria include but are not limited to the following:
- Has history of gastrointestinal disease which may affect food and drug absorption
- Has history of cancer (malignancy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Effect of Food and Water Volume on the Pharmacokinetics of the MK-0616 Final Market Formulation in Healthy Adult Participants
Enlicitide decanoate (MK-0616, the study medicine) is in a class of medicines that have been shown to reduce LDL-C. Enlicitide decanoate is different from the other medicines in this class because it is taken as a tablet and not an injection.
The goal of this study is to see what happens to doses of enlicitide decanoate in a person's body over time. During the study, researchers will measure people's blood samples for the amount of enlicitide decanoate when taken with food or on an empty stomach, or when taken with high, medium, and low volumes of water. Researchers also want to learn about the safety of enlicitide decanoate, including how well people tolerate (manage) it.
- Conditions
- Healthy
- Being tested
- Enlicitide decanoate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enlicitide decanoateDrug
Also called MK-0616
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Enlicitide Decanoate Food Effect | Experimental | Participants will be administered enlicitide decanoate on Day 1 with or without food. Receives: Drug: Enlicitide decanoate |
| Enlicitide Decanoate Water Effect | Experimental | Participants will be administered enlicitide decanoate on Day 1 with high, medium, and low volumes of water. Receives: Drug: Enlicitide decanoate |
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 Enlicitide Decanoate
Blood samples will be collected to determine the AUC0-Inf of enlicitide decanoate.
Measured: Pre-dose and at designated time points up to 1 week postdose
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate
Blood samples will be collected to determine the AUC0-24 of enlicitide decanoate.
Measured: Pre-dose and at designated time points up to 24 hours postdose
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate
Blood samples will be collected to determine the AUC0-last of enlicitide decanoate.
Measured: Pre-dose and at designated time points up to 1 week postdose
Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate
Blood samples will be collected to determine the Cmax of enlicitide decanoate.
Measured: Pre-dose and at designated time points up to 1 week postdose
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate
Blood samples will be collected to determine the Tmax of enlicitide decanoate.
Measured: Pre-dose and at designated time points up to 1 week postdose
Lag Time (tlag) of Enlicitide Decanoate in Plasma
Tlag is the time from dosing to the first appearance in plasma. Blood samples will be collected to determine the tlag of enlicitide decanoate.
Measured: Pre-dose and at designated time points up to 1 week postdose
Apparent Terminal Half-life (t1/2) of Enlicitide Decanoate
Blood samples will be collected to determine the t1/2 of enlicitide decanoate.
Measured: Pre-dose and at designated time points up to 1 week postdose
Apparent Clearance (CL/F) of Enlicitide Decanoate
Blood samples will be collected to determine the CL/F of enlicitide decanoate.
Measured: Pre-dose and at designated time points up to 1 week postdose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Decanoate
Blood samples will be collected to determine the Vz/F of enlicitide decanoate.
Measured: Pre-dose and at designated time points up to 1 week postdose
Secondary outcomes (2)
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. The number of participants who experience an AE will be reported.
Measured: Up to 14 days postdose
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. The number of participants who discontinue study due to an AE will be reported.
Measured: Up to 14 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start24 Oct 2023
- Primary completion26 Dec 2023
- Study completion26 Dec 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT06658652
- Sponsor's protocol ID
- 0616-022
- Other IDs
- MK-0616
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 26 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 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Effect of Food and Water Volume on the Pharmacokinetics of the MK-0616 Final Market Formulation in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06658652
- Acronym / sponsor ID
- 0616-022
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 26 Dec 2023 (actual)
- Study completion
- 26 Dec 2023 (actual)
- First posted
- 26 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.
Enlicitide decanoate (MK-0616, the study medicine) is in a class of medicines that have been shown to reduce LDL-C. Enlicitide decanoate is different from the other medicines in this class because it is taken as a tablet and not an injection.
The goal of this study is to see what happens to doses of enlicitide decanoate in a person's body over time. During the study, researchers will measure people's blood samples for the amount of enlicitide decanoate when taken with food or on an empty stomach, or when taken with high, medium, and low volumes of water. Researchers also want to learn about the safety of enlicitide decanoate, including how well people tolerate (manage) it.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enlicitide Decanoate Food Effect | Experimental | Drug: Enlicitide decanoateParticipants will be administered enlicitide decanoate on Day 1 with or without food. |
| Enlicitide Decanoate Water Effect | Experimental | Drug: Enlicitide decanoateParticipants will be administered enlicitide decanoate on Day 1 with high, medium, and low volumes of water. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Has body mass index (BMI) ≥18.0 and ≤32.0 kg/m^2
- Is medically healthy with no clinically significant medical history
Key exclusion criteria (3 listed)
- Has history of gastrointestinal disease which may affect food and drug absorption
- Has 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 |
|---|---|---|
| Enlicitide decanoateAlso: MK-0616Oral tablet | Drug | Enlicitide Decanoate Food Effect, Enlicitide Decanoate Water Effect |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate
Time frame: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the AUC0-Inf of enlicitide decanoate.
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate
Time frame: Pre-dose and at designated time points up to 24 hours postdose
Blood samples will be collected to determine the AUC0-24 of enlicitide decanoate.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate
Time frame: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the AUC0-last of enlicitide decanoate.
Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate
Time frame: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the Cmax of enlicitide decanoate.
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate
Time frame: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the Tmax of enlicitide decanoate.
Lag Time (tlag) of Enlicitide Decanoate in Plasma
Time frame: Pre-dose and at designated time points up to 1 week postdose
Tlag is the time from dosing to the first appearance in plasma. Blood samples will be collected to determine the tlag of enlicitide decanoate.
Apparent Terminal Half-life (t1/2) of Enlicitide Decanoate
Time frame: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the t1/2 of enlicitide decanoate.
Apparent Clearance (CL/F) of Enlicitide Decanoate
Time frame: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the CL/F of enlicitide decanoate.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Decanoate
Time frame: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the Vz/F of enlicitide decanoate.
2 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to 14 days postdose
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to 14 days 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 26 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 Enlicitide decanoate 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 26 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?
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate (time frame: Pre-dose and at designated time points up to 1 week postdose). The study lists 9 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 26 Oct 2024.