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

NCT07044479 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0616-040MK-0616-040
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Part 1-Coffee: 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 when administered with coffee

  Predose and at designated time points up to 168 hours

• Part 1-Coffee: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of Enlicitide

  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

  Predose and at designated time points up to 168 hours

• Part 1 -Coffee : Maximum Plasma Concentration (Cmax) of Enlicitide

  Blood samples will be collected to determine the maximum observed drug concentration of enlicitide when administered with coffee

  Predose and at designated time points up to 168 hours

• Part 2 -Tea: AUC0-last of Enlicitide

  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

  Predose and at designated time points up to 168 hours

• Part 2 - Tea: AUC0-Inf of Enlicitide

  Blood samples will be collected to determine the AUC0-inf of enlicitide when administered with tea.

  Predose and at designated time points up to 168 hours

• Part 2 -Tea: Cmax of Enlicitide

  Blood samples will be collected to determine the maximum observed drug concentration of enlicitide when administered with tea

  Predose and at designated time points up to 168 hours

Secondary Outcomes (4)

• Part 1 - Coffee: Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 7 weeks

• Part 2 - Tea: Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 7 weeks

• Part 1 - Coffee: Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 7 weeks

• Part 2 - Tea: Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 7 weeks

Study Arms (4)

Enlicitide Coffee Sequence 1

EXPERIMENTAL

Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with coffee in period 2.

Drug: Enlicitide

Enlicitide Coffee Sequence 2

EXPERIMENTAL

Participants will be randomized to receive enlicitide administered with coffee in period 1 and enlicitide with water in period 2.

Drug: Enlicitide

Enlicitide Tea Sequence 1

EXPERIMENTAL

Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with tea in period 2.

Drug: Enlicitide

Enlicitide Tea Sequence 2

EXPERIMENTAL

Participants will be randomized to receive enlicitide administered with tea in period 1 and enlicitide with water in period 2.

Drug: Enlicitide

Interventions

Enlicitide DRUG

Single dose of enlicitide is administered orally on day 1 of each testing period

Also known as: MK-0616, enlicitide decanoate

Enlicitide Coffee Sequence 1; Enlicitide Coffee Sequence 2; Enlicitide Tea Sequence 1; Enlicitide Tea Sequence 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion, Inc. ( Site 0001)

Tempe, Arizona, 85283, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

MK-0616

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

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: June 26, 2025
• First Posted: July 1, 2025
• Study Start: July 3, 2025
• Primary Completion: August 13, 2025
• Study Completion: August 28, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)