HealthyPhase 1NCT06658626
A Study to Evaluate the Metabolism, Excretion, and Mass Balance of [¹⁴C]Enlicitide Chloride ([¹⁴C]MK-0616) in Healthy Participants (MK-0616-016)
A Phase 1 study testing [¹⁴C]Enlicitide chloride in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The purpose of this study is to learn what happens to enlicitide chloride labeled with [¹⁴C] in a person's body over time. A label can be added to a study medicine to trace it in a person's body. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [¹⁴C]Enlicitide chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2023to 2 Aug 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is in good health.
- Has a body mass index ≥18 and ≤32 kg/m^2, inclusive.
Who cannot join
- Has a history of cancer.
- Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.
Trial locations and contacts
1 site in 1 country.
United States1 site
Labcorp Clinical Research Unit Inc. (Site 0001)
Madison, Wisconsin, 53704
About this study
Official title: An Open-label Phase 1 Study to Evaluate Metabolism, Excretion, and Mass Balance of [¹⁴C]MK-0616 in Healthy Participants
The purpose of this study is to learn what happens to enlicitide chloride labeled with [¹⁴C] in a person's body over time. A label can be added to a study medicine to trace it in a person's body.
- Conditions
- Healthy
- Being tested
- [¹⁴C]Enlicitide chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[¹⁴C]Enlicitide chlorideDrug
Also called MK-0616
IV Injection
| Study group | Role | What they receive |
|---|---|---|
| [¹⁴C]Enlicitide chloride | Experimental | Participants will receive a single dose of [¹⁴C]enlicitide chloride on Day 1. Receives: Drug: [¹⁴C]Enlicitide chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Amount of Radioactivity Excreted in Urine (Aeu)
Urine samples will be collected to determine the Aeu of [¹⁴C]enlicitide chloride.
Measured: At designated timepoints (up to 15 days)
Cumulative Amount of Radioactivity Excreted in Feces (Aef)
Fecal samples will be collected to determine the Aef of [¹⁴C]enlicitide chloride.
Measured: At designated timepoints (up to 15 days)
Cumulative Percentage of Radioactivity Excreted in Urine (feu)
Urine samples will be collected to determine the feu of [¹⁴C]enlicitide chloride.
Measured: At designated timepoints (up to 15 days)
Cumulative Percentage of Radioactivity Excreted in Feces (fef)
Fecal samples will be collected to determine the fef of [¹⁴C]enlicitide chloride.
Measured: At designated timepoints (up to 15 days)
Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t)
Plasma samples will be collected to determine the AUC0-t of enlicitide chloride.
Measured: At designated timepoints (up to 15 days)
Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf)
Plasma samples will be collected to determine the AUC0-inf of enlicitide chloride.
Measured: At designated timepoints (up to 15 days)
Plasma Enlicitide Chloride: Maximum Plasma Concentration (Cmax)
Plasma samples will be collected to determine the Cmax of enlicitide chloride.
Measured: At designated timepoints (up to 15 days)
Plasma Enlicitide Chloride: Apparent Terminal Half-life (t1/2)
Plasma samples will be collected to determine the t1/2 of enlicitide chloride.
Measured: At designated timepoints (up to 15 days)
Plasma Enlicitide Chloride: Time to Maximum Plasma Concentration (Tmax)
Plasma samples will be collected to determine the Tmax of enlicitide chloride.
Measured: At designated timepoints (up to 15 days)
Plasma Total Reactivity: AUC0-t
Plasma samples will be collected to determine the AUC0-t of total reactivity.
Measured: At designated timepoints (up to 15 days)
Plasma Total Reactivity: AUC0-inf
Plasma samples will be collected to determine the AUC0-inf of total reactivity.
Measured: At designated timepoints (up to 15 days)
Plasma Total Reactivity: Cmax
Plasma samples will be collected to determine the Cmax of total reactivity.
Measured: At designated timepoints (up to 15 days)
Plasma Total Reactivity: t1/2
Plasma samples will be collected to determine the t1/2 of total reactivity.
Measured: At designated timepoints (up to 15 days)
Plasma Total Reactivity: Tmax
Plasma samples will be collected to determine the Tmax of total reactivity.
Measured: At designated timepoints (up to 15 days)
Enlicitide Chloride to Total Radioactivity Ratio of Area Under the Concentration-Time Curve from Time 0 to the Last Detectable Sample (enlicitide chloride AUC0-x/total radioactivity AUC0-x)
Plasma samples will be collected to determine the enlicitide chloride AUC0-x/total radioactivity AUC0-x.
Measured: At designated timepoints (up to 15 days)
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 the study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 29 days
Number of Participants Who Discontinue the Study Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 29 days
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 start10 Mar 2023
- Primary completion2 Aug 2023
- Study completion2 Aug 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT06658626
- Sponsor's protocol ID
- 0616-016
- Other IDs
- MK-0616-016
- 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
- An Open-label Phase 1 Study to Evaluate Metabolism, Excretion, and Mass Balance of [¹⁴C]MK-0616 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06658626
- Acronym / sponsor ID
- 0616-016
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 2 Aug 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.
The purpose of this study is to learn what happens to enlicitide chloride labeled with [¹⁴C] in a person's body over time. A label can be added to a study medicine to trace it in a person's body.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [¹⁴C]Enlicitide chloride | Experimental | Drug: [¹⁴C]Enlicitide chlorideParticipants will receive a single dose of [¹⁴C]enlicitide chloride on Day 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is in good health.
- Has a body mass index ≥18 and ≤32 kg/m^2, inclusive.
Key exclusion criteria (2 listed)
- Has a history of cancer.
- Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.
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 |
|---|---|---|
| [¹⁴C]Enlicitide chlorideAlso: MK-0616IV Injection | Drug | [¹⁴C]Enlicitide chloride |
Primary outcome
Cumulative Amount of Radioactivity Excreted in Urine (Aeu)
Time frame: At designated timepoints (up to 15 days)
Urine samples will be collected to determine the Aeu of [¹⁴C]enlicitide chloride.
Cumulative Amount of Radioactivity Excreted in Feces (Aef)
Time frame: At designated timepoints (up to 15 days)
Fecal samples will be collected to determine the Aef of [¹⁴C]enlicitide chloride.
Cumulative Percentage of Radioactivity Excreted in Urine (feu)
Time frame: At designated timepoints (up to 15 days)
Urine samples will be collected to determine the feu of [¹⁴C]enlicitide chloride.
Cumulative Percentage of Radioactivity Excreted in Feces (fef)
Time frame: At designated timepoints (up to 15 days)
Fecal samples will be collected to determine the fef of [¹⁴C]enlicitide chloride.
Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t)
Time frame: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the AUC0-t of enlicitide chloride.
Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf)
Time frame: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the AUC0-inf of enlicitide chloride.
Plasma Enlicitide Chloride: Maximum Plasma Concentration (Cmax)
Time frame: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the Cmax of enlicitide chloride.
Plasma Enlicitide Chloride: Apparent Terminal Half-life (t1/2)
Time frame: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the t1/2 of enlicitide chloride.
Plasma Enlicitide Chloride: Time to Maximum Plasma Concentration (Tmax)
Time frame: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the Tmax of enlicitide chloride.
Plasma Total Reactivity: AUC0-t
Time frame: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the AUC0-t of total reactivity.
Plasma Total Reactivity: AUC0-inf
Time frame: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the AUC0-inf of total reactivity.
Plasma Total Reactivity: Cmax
Time frame: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the Cmax of total reactivity.
Plasma Total Reactivity: t1/2
Time frame: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the t1/2 of total reactivity.
Plasma Total Reactivity: Tmax
Time frame: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the Tmax of total reactivity.
Enlicitide Chloride to Total Radioactivity Ratio of Area Under the Concentration-Time Curve from Time 0 to the Last Detectable Sample (enlicitide chloride AUC0-x/total radioactivity AUC0-x)
Time frame: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the enlicitide chloride AUC0-x/total radioactivity AUC0-x.
2 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 29 days
Number of Participants Who Discontinue the Study Due to an AE
Time frame: Up to approximately 29 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 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 [¹⁴C]Enlicitide chloride 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 2 inclusion and 2 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?
Cumulative Amount of Radioactivity Excreted in Urine (Aeu) (time frame: At designated timepoints (up to 15 days)). The study lists 15 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.