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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Enlicitide Decanoate; Drug: Atorvastatin

• Registration Number: NCT06699355
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-08
• Primary Completion: 2023-12-29
• Study Completion: 2023-12-29
• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Enlicitide Decanoate + Atorvastatin	Enlicitide Decanoate	Participants receive a single oral dose of enlicitide decanoate plus a single oral dose of atorvastatin (Treatment B) on Day 1.
Atorvastatin	Atorvastatin	Participants receive a single oral dose of atorvastatin (Treatment A) on Day 1.
Enlicitide Decanoate + Atorvastatin	Atorvastatin	Participants receive a single oral dose of enlicitide decanoate plus a single oral dose of atorvastatin (Treatment B) on Day 1.
Enlicitide Decanoate	Enlicitide Decanoate	Participants receive a single oral dose of enlicitide decanoate (Treatment C) on Day 1.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE)	Up to approximately 10 weeks	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.
Number of Participants Who Discontinue Study Treatment Due to an AE	Up to approximately 6 weeks	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.

Trial Locations

Locations (1)

Celerion (Site 0001); 🇺🇸 Lincoln, Nebraska, United States