A Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants (MK-0616-035)

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: Enlicitide

• Registration Number: NCT06880874
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The goal of the study is to learn what happens to different forms of enlicitide medications in a healthy person's body over time. Researchers will compare the amount of enlicitide in the healthy person's body over time when enlicitide is given in different formulations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Study First Posted: 2025-03-18
• Status Verified: 2025-04
• Study Start: 2025-04-02
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-04-18
• Study Completion: 2025-05-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

The main inclusion criteria include but are not limited to the following:

• Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
• Has body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2

Exclusion Criteria

The main exclusion criteria include but are not limited to the following:

• Has history of gastrointestinal disease which may affect food and drug absorption or has had a gastric bypass or similar surgery
• Has history of cancer (malignancy)
• Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A: enlicitide reference tablet	Enlicitide	Participants receive a single oral dose of enlicitide reference tablet.
Treatment B: enlicitide test tablet	Enlicitide	Participants receive a single oral dose of enlicitide test tablet.

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of enlicitide in plasma	Pre-dose and at designated time points up to 24 hours post dose	Blood samples will be collected to determine the AUC0-24hr of enlicitide.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of enlicitide in plasma	Pre-dose and at designated time points up to 168 hours post dose	Blood samples will be collected to determine the AUC0-Last of enlicitide.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of enlicitide in plasma	Pre-dose and at designated time points up to 168 hours post dose	Blood samples will be collected to determine the AUC0-Inf of enlicitide.
Maximum Plasma Concentration (Cmax) of enlicitide in plasma	Pre-dose and at designated time points up to 168 hours post dose	Blood samples will be collected to determine the Cmax of enlicitide.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 14 days	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.
Number of Participants Who Discontinue Study Treatment Due to an AE	Up to approximately 8 days	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 treatment due to an AE will be reported.

Trial Locations

Locations (1)

Celerion ( Site 0001); 🇺🇸 Tempe, Arizona, United States