Healthy
Conditions
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.
Interventions
DRUGEnlicitide
Single dose of enlicitide is administered orally on day 1 of each testing period
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
United States
Outcome results
None listed