Clinical trial NCT06609512: A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033)
Official title: A Clinical Study to Evaluate the Effect of Fasting Duration on the Pharmacokinetics of the Enlicitide in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the study is to learn what happens to enlicitide decanoate in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare what happens to enlicitide in a healthy person's body over time when enlicitide is taken with or without food. Enlicitide decanoate will be referred to as "enlicitide" throughout.


Eligibility criteria: Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

- Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery
* History of cancer (malignancy)
* Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or Human immunodeficiency virus (HIV)
* History of a major surgery
* Is lactose intolerant

Primary outcomes:
measure: Area Under the Concentration versus Time Curve from 0 to Infinity (AUC0-inf) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 168 hours post dose
measure: Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 24 hours post dose
measure: Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 168 hours post dose
measure: Maximum plasma concentration (Cmax) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 168 hours post dose
measure: Time to maximum plasma concentration (Tmax) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 168 hours post dose
measure: Apparent terminal half-life (t1/2) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 168 hours post dose
measure: Apparent Clearance (CL/F) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 168 hours post dose
measure: Apparent volume of distribution during terminal phase (Vz/F) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 168 hours post dose
measure: Lag Time (tlag) of enlicitide in plasma
timeFrame: Pre-dose and at designated time points up to 168 hours post dose
Secondary outcomes:
measure: Number of participants who experience one or more adverse events (AEs)
timeFrame: Up to ~ 14 days
measure: Number of participants who discontinue study intervention due to an AE
timeFrame: Up to ~ 14 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion ( Site 0001)
state: Arizona
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: