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Completed

NCT Number: NCT06699355

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

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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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Enlicitide Decanoate

Drug

Oral administration

atorvastatin

Drug

Oral administration

Other names: Lipitor

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Atorvastatin and its Metabolites

    Time frame: At designated timepoints (up to approximately 8 days)

    Blood samples will be collected to determine the AUC0-Inf of atorvastatin and its metabolites.

  2. Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Atorvastatin and its Metabolites

    Time frame: At designated timepoints (up to approximately 8 days)

    Blood samples will be collected to determine the AUC0-Last of atorvastatin and its metabolites.

  3. Maximum Plasma Concentration (Cmax) of Atorvastatin and its Metabolites

    Time frame: At designated timepoints (up to approximately 8 days)

    Blood samples will be collected to determine the Cmax of atorvastatin and its metabolites.

  4. Time to Maximum Plasma Concentration (Tmax) of Atorvastatin and its Metabolites

    Time frame: At designated timepoints (up to approximately 8 days)

    Blood samples will be collected to determine the Tmax of atorvastatin and its metabolites.

  5. Apparent Terminal Half-Life (t1/2) of Atorvastatin and its Metabolites

    Time frame: At designated timepoints (up to approximately 8 days)

    Blood samples will be collected to determine the t1/2 of atorvastatin and its metabolites.

  6. Apparent Clearance (CL/F) of Atorvastatin

    Time frame: At designated timepoints (up to approximately 8 days)

    Blood samples will be collected to determine the CL/F of atorvastatin.

  7. Apparent Volume of Distribution (Vz/F) of Atorvastatin

    Time frame: At designated timepoints (up to approximately 8 days)

    Blood samples will be collected to determine the Vz/F of atorvastatin.

  8. Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24hrs) of Enlicitide Decanoate

    Time frame: At designated timepoints (up to approximately 24 hours)

    Blood samples will be collected to determine the AUC0-24hrs of enlicitide decanoate.

  9. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate

    Time frame: At designated timepoints (up to approximately 8 days)

    Blood samples will be collected to determine the AUC0-Inf of enlicitide decanoate.

  10. Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate

    Time frame: At designated timepoints (up to approximately 8 days)

    Blood samples will be collected to determine the AUC0-Last of enlicitide decanoate.

  11. Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate

    Time frame: At designated timepoints (up to approximately 8 days)

    Blood samples will be collected to determine the Cmax of enlicitide decanoate.

  12. Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate

    Time frame: At designated timepoints (up to approximately 8 days)

    Blood samples will be collected to determine the Tmax of enlicitide decanoate.

  13. Apparent Terminal Half-Life (t1/2) of Enlicitide Decanoate

    Time frame: At designated timepoints (up to approximately 8 days)

    Blood samples will be collected to determine the t1/2 of enlicitide decanoate.

  14. Apparent Clearance (CL/F) of Enlicitide Decanoate

    Time frame: At designated timepoints (up to approximately 8 days)

    Blood samples will be collected to determine the CL/F of enlicitide decanoate.

  15. Apparent Volume of Distribution (Vz/F) of Enlicitide Decanoate

    Time frame: At designated timepoints (up to approximately 8 days)

    Blood samples will be collected to determine the Vz/F of enlicitide decanoate.

Secondary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: 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.

  2. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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