A Clinical Study of How Coffee and Tea Affect Enlicitide in Healthy Volunteers (MK-0616-040)
NCT ID: NCT07044479
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2025-07-03
2025-08-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Plasma Caffeine Concentration After Oral Consumption of Caffeinated Beverages With Varied Bioactive Compounds in Healthy Volunteers
NCT04281758
Effects of Energy Drinks
NCT02727920
Energy Drink Effects on Performance, Mood, and Cardiovascular Outcomes
NCT05559372
The Effect of Energy Drink Ingredients on Cardiovascular Function in Men and Women 18-39 Years Old
NCT04149717
Characterizing the Pharmacokinetic Profile of a Novel Encapsulated Caffeine Beverage and Associated Mood and Physiological Effects
NCT05096780
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Enlicitide Coffee Sequence 1
Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with coffee in period 2.
Enlicitide
Single dose of enlicitide is administered orally on day 1 of each testing period
Enlicitide Coffee Sequence 2
Participants will be randomized to receive enlicitide administered with coffee in period 1 and enlicitide with water in period 2.
Enlicitide
Single dose of enlicitide is administered orally on day 1 of each testing period
Enlicitide Tea Sequence 1
Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with tea in period 2.
Enlicitide
Single dose of enlicitide is administered orally on day 1 of each testing period
Enlicitide Tea Sequence 2
Participants will be randomized to receive enlicitide administered with tea in period 1 and enlicitide with water in period 2.
Enlicitide
Single dose of enlicitide is administered orally on day 1 of each testing period
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Enlicitide
Single dose of enlicitide is administered orally on day 1 of each testing period
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* History of gastrointestinal disease which might affect food and drug absorption, or has had gastric bypass or similar surgery.
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Celerion, Inc. ( Site 0001)
Tempe, Arizona, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Merck Clinical Trials Information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MK-0616-040
Identifier Type: OTHER
Identifier Source: secondary_id
0616-040
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.