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

A Clinical Study to Evaluate the Effect of MK-0616 and Atorvastatin on Their Respective Pharmacokinetics in Healthy Adult Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Atorvastatin; Drug: Enlicitide Decanoate

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion (Site 0001)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atorvastatin; Participants receive a single oral dose of atorvastatin (Treatment A) on Day 1.	Drug: Atorvastatin; Oral administration; Other Names: Lipitor
Experimental: Enlicitide Decanoate + Atorvastatin; Participants receive a single oral dose of enlicitide decanoate plus a single oral dose of atorvastatin (Treatment B) on Day 1.	Drug: Atorvastatin; Oral administration; Other Names: Lipitor; Drug: Enlicitide Decanoate; Oral administration
Experimental: Enlicitide Decanoate; Participants receive a single oral dose of enlicitide decanoate (Treatment C) on Day 1.	Drug: Enlicitide Decanoate; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Atorvastatin and its Metabolites	Blood samples will be collected to determine the AUC0-Inf of atorvastatin and its metabolites.	At designated timepoints (up to approximately 8 days)
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Atorvastatin and its Metabolites	Blood samples will be collected to determine the AUC0-Last of atorvastatin and its metabolites.	At designated timepoints (up to approximately 8 days)
Maximum Plasma Concentration (Cmax) of Atorvastatin and its Metabolites	Blood samples will be collected to determine the Cmax of atorvastatin and its metabolites.	At designated timepoints (up to approximately 8 days)
Time to Maximum Plasma Concentration (Tmax) of Atorvastatin and its Metabolites	Blood samples will be collected to determine the Tmax of atorvastatin and its metabolites.	At designated timepoints (up to approximately 8 days)
Apparent Terminal Half-Life (t1/2) of Atorvastatin and its Metabolites	Blood samples will be collected to determine the t1/2 of atorvastatin and its metabolites.	At designated timepoints (up to approximately 8 days)
Apparent Clearance (CL/F) of Atorvastatin	Blood samples will be collected to determine the CL/F of atorvastatin.	At designated timepoints (up to approximately 8 days)
Apparent Volume of Distribution (Vz/F) of Atorvastatin	Blood samples will be collected to determine the Vz/F of atorvastatin.	At designated timepoints (up to approximately 8 days)
Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24hrs) of Enlicitide Decanoate	Blood samples will be collected to determine the AUC0-24hrs of enlicitide decanoate.	At designated timepoints (up to approximately 24 hours)
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate	Blood samples will be collected to determine the AUC0-Inf of enlicitide decanoate.	At designated timepoints (up to approximately 8 days)
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate	Blood samples will be collected to determine the AUC0-Last of enlicitide decanoate.	At designated timepoints (up to approximately 8 days)
Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate	Blood samples will be collected to determine the Cmax of enlicitide decanoate.	At designated timepoints (up to approximately 8 days)
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate	Blood samples will be collected to determine the Tmax of enlicitide decanoate.	At designated timepoints (up to approximately 8 days)
Apparent Terminal Half-Life (t1/2) of Enlicitide Decanoate	Blood samples will be collected to determine the t1/2 of enlicitide decanoate.	At designated timepoints (up to approximately 8 days)
Apparent Clearance (CL/F) of Enlicitide Decanoate	Blood samples will be collected to determine the CL/F of enlicitide decanoate.	At designated timepoints (up to approximately 8 days)
Apparent Volume of Distribution (Vz/F) of Enlicitide Decanoate	Blood samples will be collected to determine the Vz/F of enlicitide decanoate.	At designated timepoints (up to approximately 8 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience an Adverse Event (AE)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.	Up to approximately 10 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.	Up to approximately 6 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): December 29, 2023

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Estimated): November 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 0616-024; MK-0616-024 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No