A Clinical Study to Evaluate Enlicitide (MK-0616) Formulations in Healthy Adult Participants (MK-0616-035)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Enlicitide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06880874

0616-035

MK-0616-035 (Other Identifier)

Details and patient eligibility

About

The goal of the study is to learn what happens to different forms of enlicitide medications in a healthy person's body over time. Researchers will compare the amount of enlicitide in the healthy person's body over time when enlicitide is given in different formulations.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

• Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
• 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:

• Has history of gastrointestinal disease which may affect food and drug absorption or has had a gastric bypass or similar surgery
• Has history of cancer (malignancy)
• Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Treatment A: enlicitide reference tablet

Experimental group

Description:

Participants receive a single oral dose of enlicitide reference tablet.

Treatment:

Drug: Enlicitide

Treatment B: enlicitide test tablet

Experimental group

Description:

Participants receive a single oral dose of enlicitide test tablet.

Treatment:

Drug: Enlicitide