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

Merck Sharp & Dohme LLC60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

EnlicitideDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Celerion, Inc. ( Site 0001)

Tempe, Arizona, United States

Outcomes

Primary Outcomes

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