A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy

Treatments: Drug: MK-0616A; Drug: Enlicitide; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07300280

0616A-039

Details and patient eligibility

About

This goal of this trial is to learn about two medicines, enlicitide and rosuvastatin, in healthy people. Researchers will compare the amounts of enlicitide and rosuvastatin in a person's body over time, when they are given as separate medicines and when they are combined into one tablet.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

• Is medically healthy with no clinically significant medical history
• Is a non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to study entry

Exclusion Criteria:

• Is unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to study entry
• Is a female participant of childbearing potential

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Enclidite + Rosuvastatin

Experimental group

Description:

Participants will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet

Treatment:

Drug: Rosuvastatin

Drug: Enlicitide

MK-0616A

Experimental group

Description:

Participants will receive a single dose of MK-0616A

Treatment:

Drug: MK-0616A