A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031)

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Enlicitide; Drug: Digoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06597760

MK-0616-031 (Other Identifier)

CA41814 (Other Identifier)

0616-031

Details and patient eligibility

About

Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward.

The purpose of this study is to learn the effect of this new study medicine enlicitide on digoxin (medicine used in heart disease) over time (a pharmacokinetic or PK study). Researchers will compare what happens to digoxin in the body over time when it is given with this new study medicine enlicitide in healthy adult participants.

Enrollment: 24 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

• Is in good health before randomization
• Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive

Exclusion criteria

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

• Has a history of clinically significant psychiatric, immunological, gastrointestinal, cardiovascular abnormalities or diseases.
• Has a history of cancer.
• Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Sequence 1: 0.25mg Digoxin-->0.25mg Digoxin plus 20mg enlicitide/180mg Sodium Caprate

Experimental group

Description:

Participants will receive 1 tablet of 0.25mg Digoxin on Day 1 of period 1 and 1 tablet of 0.25mg Digoxin coadministered with 1 tablet of 20 mg enlicitide/180 mg sodium caprate on Day 1 of Period 2.

Treatment:

Drug: Digoxin

Drug: Enlicitide

Sequence 2: 0.25mg Digoxin plus 20mg enlicitide/180mg Sodium Caprate-->0.25mg Digoxin

Experimental group

Description:

Participants will receive 1 tablet of 0.25mg Digoxin coadministered with 1 tablet of 20 mg enlicitide/180 mg sodium caprate on Day 1 of Period 1 and will receive 1 tablet of 0.25mg Digoxin on Day 1 of period 2.

Treatment:

Drug: Digoxin

Drug: Enlicitide