A Clinical Study of the Effect of Enlicitide (MK-0616) Formulations in Healthy Participants (MK-0616-041)
A Clinical Study to Evaluate the Relative Bioavailability of Enlicitide Tablet Formulations Compared to the Reference Formulation in Healthy Adult Participants
2 other identifiers
interventional
30
1 country
1
Brief Summary
The goal of this study is to learn what happens to enlicitide (MK-0616) in a healthy person's body over time (pharmacokinetic or PK study). Researchers also want to learn about the safety of enlicitide and if people tolerate it.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Mar 2026
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2026
CompletedFirst Posted
Study publicly available on registry
March 19, 2026
CompletedStudy Start
First participant enrolled
March 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2026
CompletedJune 2, 2026
May 1, 2026
2 months
March 16, 2026
June 1, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of enlicitide
Blood samples will be collected to determine the AUC0-Last of enlicitide.
At designated timepoints up to approximately 50 days
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of enlicitide
Blood samples will be collected to determine the AUC0-Inf of enlicitide.
At designated timepoints up to approximately 50 days
Maximum Plasma Concentration (Cmax) of enlicitide
Blood samples will be collected to estimate Cmax of enlicitide.
At designated timepoints up to approximately 50 days
Secondary Outcomes (2)
Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 56 days
Number of Participants Who Discontinue Study Intervention Due to an AE
Up to approximately 56 days
Study Arms (3)
Dose regimen A
EXPERIMENTALParticipants receive enlicitide orally at dose regimen A.
Dose regimen B
EXPERIMENTALParticipants receive enlicitide orally at dose regimen B.
Dose regimen C
ACTIVE COMPARATORParticipants receive enlicitide orally at dose regimen C.
Interventions
Eligibility Criteria
You may qualify if:
- Is in good health
- Has a body-mass index (BMI) between 18 and 32 kg/m\^2
You may not qualify if:
- Has a history of clinically significant gastrointestinal disease that may impact drug absorption
- Has a history of cancer (malignancy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Celerion ( Site 0001)
Lincoln, Nebraska, 68502, United States
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2026
First Posted
March 19, 2026
Study Start
March 23, 2026
Primary Completion
May 18, 2026
Study Completion
May 25, 2026
Last Updated
June 2, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf