A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Atorvastatin in Healthy Adult Participants (MK-0616-024)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Atorvastatin; Drug: Enlicitide Decanoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT06699355

0616-024

MK-0616-024 (Other Identifier)

Details and patient eligibility

About

The goal of this study is to learn what happens to enlicitide decanoate and atorvastatin in a healthy person's body over time. Researchers want to learn what happens to enlicitide decanoate in the body when it is given with and without another medicine called atorvastatin and what happens to atorvastatin in the body when it is given with or without enlicitide decanoate.

Enrollment: 18 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, standard and orthostatic vital signs, and electrocardiograms (ECGs)

Exclusion criteria

• History of gastrointestinal disease which may affect food and drug absorption or has had a gastric bypass or similar surgery
• History of cancer (malignancy)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Atorvastatin

Experimental group

Description:

Participants receive a single oral dose of atorvastatin (Treatment A) on Day 1.

Treatment:

Drug: Atorvastatin

Enlicitide Decanoate + Atorvastatin

Experimental group

Description:

Participants receive a single oral dose of enlicitide decanoate plus a single oral dose of atorvastatin (Treatment B) on Day 1.

Treatment:

Drug: Enlicitide Decanoate

Drug: Atorvastatin

Enlicitide Decanoate

Experimental group

Description:

Participants receive a single oral dose of enlicitide decanoate (Treatment C) on Day 1.

Treatment:

Drug: Enlicitide Decanoate