HealthyPhase 1NCT06772792
A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Alendronate in Healthy Adult Participants (MK-0616-027)
A Phase 1 study testing Alendronate and Enlicitide Decanoate in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of this study is to learn what happens to a single dose of alendronate over time in a healthy participant's body when the participant is given a single dose of enlicitide decanoate. Researchers want to learn how safe and tolerable is the co-administration of enlicitide decanoate and alendronate. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Alendronate and Enlicitide Decanoate
- 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
- 23 Apr 2024to 21 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs)
- Has a body mass index (BMI) ≥18.0 kg/m^2 and ≤32.0 kg/m^2 (inclusive)
Who cannot join
- Has a history or presence of abnormalities of the esophagus which delay emptying such as stricture or achalasia
- Has a history of cancer (malignancy)
- Has a history of gastrointestinal disease which may affect food and drug absorption
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 the Pharmacokinetics of Alendronate in Healthy Adult Participants
The goal of this study is to learn what happens to a single dose of alendronate over time in a healthy participant's body when the participant is given a single dose of enlicitide decanoate. Researchers want to learn how safe and tolerable is the co-administration of enlicitide decanoate and alendronate.
- Conditions
- Healthy
- Being tested
- Alendronate, Enlicitide Decanoate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateDrug
Also called Fosamax®
Oral administration
Enlicitide DecanoateDrug
Also called MK-0616
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Alendronate | Experimental | Participants receive a single oral dose of alendronate on Day 1 OR participants receive a single oral dose of alendronate on Day 15 depending on randomization. Receives: Drug: Alendronate |
| Alendronate + Enlicitide Decanoate | Experimental | Participants receive an oral dose of alendronate plus an oral dose of enlicitide decanoate on Day 1 OR participants receive an oral dose of alendronate plus an oral dose of enlicitide decanoate on Day 15 depending on randomization. Receives: Drug: Alendronate; 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 Last (AUC0-Last) of Alendronate
Blood samples will be collected to determine the AUC0-Last of alendronate.
Measured: At designated timepoints (up to approximately 10 hours post-dose)
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Alendronate
Blood samples will be collected to determine the AUC0-Inf of alendronate.
Measured: At designated timepoints (up to approximately 10 hours post-dose)
Maximum Plasma Concentration (Cmax) of Alendronate
Blood samples will be collected to determine the Cmax of alendronate.
Measured: At designated timepoints (up to approximately 10 hours post-dose)
Time to Maximum Plasma Concentration (Tmax) of Alendronate
Blood samples will be collected to determine the Tmax of alendronate.
Measured: At designated timepoints (up to approximately 10 hours post-dose)
Apparent Terminal Half-Life (t1/2) of Alendronate
Blood samples will be collected to determine the t1/2 of alendronate.
Measured: At designated timepoints (up to approximately 10 hours post-dose)
Apparent Clearance (CL/F) of Alendronate
Blood samples will be collected to determine the CL/F of alendronate.
Measured: At designated timepoints (up to approximately 10 hours post-dose)
Apparent Volume of Distribution (Vz/F) of Alendronate
Blood samples will be collected to determine Vz/F of alendronate.
Measured: At designated timepoints (up to approximately 10 hours post-dose)
Secondary outcomes (4)
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Measured: Up to approximately 8 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 3 weeks
Total Amount of Alendronate Excreted Unchanged Over a Period of 48 Hours (Ae0-48) after Alendronate Administration
Urine samples will be collected to determine the Ae0-48 of alendronate.
Measured: At designated timepoints (up to approximately 48 hours post-dose)
Maximum Rate (Rmax) of Alendronate Excretion
Urine samples will be collected to determine the Rmax of alendronate excretion.
Measured: At designated timepoints (up to approximately 48 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 posted14 Jan 2025
- Study start23 Apr 2024
- Primary completion21 Jun 2024
- Study completion21 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
- NCT06772792
- Sponsor's protocol ID
- 0616-027
- Other IDs
- MK-0616-027
- Status last verified
- Feb 2025
- First submitted
- 9 Jan 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 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 the Pharmacokinetics of Alendronate in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06772792
- Acronym / sponsor ID
- 0616-027
- 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
- 23 Apr 2024 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 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 goal of this study is to learn what happens to a single dose of alendronate over time in a healthy participant's body when the participant is given a single dose of enlicitide decanoate. Researchers want to learn how safe and tolerable is the co-administration of enlicitide decanoate and alendronate.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alendronate | Experimental | Drug: AlendronateParticipants receive a single oral dose of alendronate on Day 1 OR participants receive a single oral dose of alendronate on Day 15 depending on randomization. |
| Alendronate + Enlicitide Decanoate | Experimental | Drug: Alendronate, Drug: Enlicitide DecanoateParticipants receive an oral dose of alendronate plus an oral dose of enlicitide decanoate on Day 1 OR participants receive an oral dose of alendronate plus an oral dose of enlicitide decanoate on Day 15 depending on randomization. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Has no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs)
- Has a body mass index (BMI) ≥18.0 kg/m^2 and ≤32.0 kg/m^2 (inclusive)
Key exclusion criteria (3 listed)
- Has a history or presence of abnormalities of the esophagus which delay emptying such as stricture or achalasia
- Has a history of cancer (malignancy)
- Has a history of gastrointestinal disease which may affect food and drug absorption
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 |
|---|---|---|
| AlendronateAlso: Fosamax®Oral administration | Drug | Alendronate, Alendronate + Enlicitide Decanoate |
| Enlicitide DecanoateAlso: MK-0616Oral administration | Drug | Alendronate + Enlicitide Decanoate |
Primary outcome
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Alendronate
Time frame: At designated timepoints (up to approximately 10 hours post-dose)
Blood samples will be collected to determine the AUC0-Last of alendronate.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Alendronate
Time frame: At designated timepoints (up to approximately 10 hours post-dose)
Blood samples will be collected to determine the AUC0-Inf of alendronate.
Maximum Plasma Concentration (Cmax) of Alendronate
Time frame: At designated timepoints (up to approximately 10 hours post-dose)
Blood samples will be collected to determine the Cmax of alendronate.
Time to Maximum Plasma Concentration (Tmax) of Alendronate
Time frame: At designated timepoints (up to approximately 10 hours post-dose)
Blood samples will be collected to determine the Tmax of alendronate.
Apparent Terminal Half-Life (t1/2) of Alendronate
Time frame: At designated timepoints (up to approximately 10 hours post-dose)
Blood samples will be collected to determine the t1/2 of alendronate.
Apparent Clearance (CL/F) of Alendronate
Time frame: At designated timepoints (up to approximately 10 hours post-dose)
Blood samples will be collected to determine the CL/F of alendronate.
Apparent Volume of Distribution (Vz/F) of Alendronate
Time frame: At designated timepoints (up to approximately 10 hours post-dose)
Blood samples will be collected to determine Vz/F of alendronate.
4 secondary outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 8 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 3 weeks
Total Amount of Alendronate Excreted Unchanged Over a Period of 48 Hours (Ae0-48) after Alendronate Administration
Time frame: At designated timepoints (up to approximately 48 hours post-dose)
Maximum Rate (Rmax) of Alendronate Excretion
Time frame: At designated timepoints (up to approximately 48 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 18 Feb 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/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 Alendronate and 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 2 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 18 Feb 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 Last (AUC0-Last) of Alendronate (time frame: At designated timepoints (up to approximately 10 hours post-dose)). The study lists 7 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 18 Feb 2025; AzTrials last refreshed its copy on 31 Oct 2026.