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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-08

Study Completion Date

2023-12-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atorvastatin

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

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Oral administration

Enlicitide Decanoate + Atorvastatin

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

Group Type EXPERIMENTAL

Enlicitide Decanoate

Intervention Type DRUG

Oral administration

Atorvastatin

Intervention Type DRUG

Oral administration

Enlicitide Decanoate

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

Group Type EXPERIMENTAL

Enlicitide Decanoate

Intervention Type DRUG

Oral administration

Interventions

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Enlicitide Decanoate

Oral administration

Intervention Type DRUG

Atorvastatin

Oral administration

Intervention Type DRUG

Other Intervention Names

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Lipitor

Eligibility Criteria

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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)

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes