A Clinical Study of How Coffee and Tea Affect Enlicitide in Healthy Volunteers (MK-0616-040)

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Drug: Enlicitide

• Registration Number: NCT07044479
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The goal of this study is to learn what happens to enlicitide in a person's body over time when enlicitide is taken at the same time as coffee or tea. Researchers will measure the amount of enlicitide in the blood when taken with coffee or tea compared with enlicitide taken with water.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-26
• Status Verified: 2025-07
• Study First Posted: 2025-07-01
• Study Start: 2025-07-03
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24
• Primary Completion: 2025-08-13
• Study Completion: 2025-08-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

• Is in good health
• Is a non-smoker for at least 3 months prior to study entry
• Part 1 only: Consumes at least 1 cup of caffeinated coffee per day
• Part 2 only: Consumes at least 1 cup of caffeinated tea per day

Exclusion Criteria

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

• Has a history or presence of clinically significant medical or psychiatric condition or disease
• History of gastrointestinal disease which might affect food and drug absorption, or has had gastric bypass or similar surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Enlicitide Coffee Sequence 1	Enlicitide	Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with coffee in period 2.
Enlicitide Coffee Sequence 2	Enlicitide	Participants will be randomized to receive enlicitide administered with coffee in period 1 and enlicitide with water in period 2.
Enlicitide Tea Sequence 1	Enlicitide	Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with tea in period 2.
Enlicitide Tea Sequence 2	Enlicitide	Participants will be randomized to receive enlicitide administered with tea in period 1 and enlicitide with water in period 2.

Primary Outcome Measures

Name	Time	Method
Part 1-Coffee: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide	Predose and at designated time points up to 168 hours	Blood samples will be collected to determine the AUC0-inf of enlicitide when administered with coffee
Part 2 -Tea: Cmax of Enlicitide	Predose and at designated time points up to 168 hours	Blood samples will be collected to determine the maximum observed drug concentration of enlicitide when administered with tea
Part 1-Coffee: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Enlicitide	Predose and at designated time points up to 168 hours	Blood samples will be collected to determine the AUC from time 0 to the time of last quantifiable sample of enlicitide when administered with coffee
Part 1 -Coffee : Maximum Plasma Concentration (Cmax) of Enlicitide	Predose and at designated time points up to 168 hours	Blood samples will be collected to determine the maximum observed drug concentration of enlicitide when administered with coffee
Part 2 -Tea: AUC0-last of Enlicitide	Predose and at designated time points up to 168 hours	Blood samples will be collected to determine the AUC from time 0 to the time of last quantifiable sample of enlicitide when administered with tea
Part 2 - Tea: AUC0-Inf of Enlicitide	Predose and at designated time points up to 168 hours	Blood samples will be collected to determine the AUC0-inf of enlicitide when administered with tea.

Secondary Outcome Measures

Name	Time	Method
Part 2 - Tea: Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 7 weeks	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.
Part 1 - Coffee: Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 7 weeks	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.
Part 1 - Coffee: Number of Participants Who Discontinue Study Treatment Due to an AE	Up to approximately 7 weeks	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.
Part 2 - Tea: Number of Participants Who Discontinue Study Treatment Due to an AE	Up to approximately 7 weeks	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, Inc. ( Site 0001); 🇺🇸 Tempe, Arizona, United States