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

NCT06699355 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0616-024MK-0616-024
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (2)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 10 weeks

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 6 weeks

Study Arms (3)

Atorvastatin

EXPERIMENTAL

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

Drug: Atorvastatin

Enlicitide Decanoate + Atorvastatin

EXPERIMENTAL

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

Drug: Enlicitide Decanoate; Drug: Atorvastatin

Enlicitide Decanoate

EXPERIMENTAL

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

Drug: Enlicitide Decanoate

Interventions

Enlicitide Decanoate DRUG

Oral administration

Enlicitide Decanoate; Enlicitide Decanoate + Atorvastatin

Atorvastatin DRUG

Oral administration

Also known as: Lipitor

Atorvastatin; Enlicitide Decanoate + Atorvastatin

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: November 8, 2023
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)