A Clinical Study to Evaluate the Effects of Coffee and Tea on the Pharmacokinetics of Enlicitide in Healthy Adult Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Part 1-Coffee: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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 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.
Arms & Interventions
Enlicitide Coffee Sequence 1
Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with coffee in period 2.
Intervention: Enlicitide (Drug)
Enlicitide Coffee Sequence 2
Participants will be randomized to receive enlicitide administered with coffee in period 1 and enlicitide with water in period 2.
Intervention: Enlicitide (Drug)
Enlicitide Tea Sequence 1
Participants will be randomized to receive enlicitide administered with water in period 1 and enlicitide with tea in period 2.
Intervention: Enlicitide (Drug)
Enlicitide Tea Sequence 2
Participants will be randomized to receive enlicitide administered with tea in period 1 and enlicitide with water in period 2.
Intervention: Enlicitide (Drug)
Outcomes
Primary Outcomes
Part 1-Coffee: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Part 2 - Tea: Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 7 weeks)
- Part 1 - Coffee: 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)