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Completed

NCT Number: NCT06772792

A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Alendronate in Healthy Adult Participants (MK-0616-027)

The goal of this study is to learn what happens to a single dose of alendronate over time in a healthy participant's body when the participant is given a single dose of enlicitide decanoate. Researchers want to learn how safe and tolerable is the co-administration of enlicitide decanoate and alendronate.

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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

  • Has no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs)
  • Has a body mass index (BMI) ≥18.0 kg/m^2 and ≤32.0 kg/m^2 (inclusive)

Exclusion criteria

  • Has a history or presence of abnormalities of the esophagus which delay emptying such as stricture or achalasia
  • Has a history of cancer (malignancy)
  • Has a history of gastrointestinal disease which may affect food and drug absorption

Treatment and study plan

Alendronate

Drug

Oral administration

Other names: Fosamax®

Enlicitide Decanoate

Drug

Oral administration

Other names: MK-0616

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Alendronate

    Time frame: At designated timepoints (up to approximately 10 hours post-dose)

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

  2. Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Alendronate

    Time frame: At designated timepoints (up to approximately 10 hours post-dose)

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

  3. Maximum Plasma Concentration (Cmax) of Alendronate

    Time frame: At designated timepoints (up to approximately 10 hours post-dose)

    Blood samples will be collected to determine the Cmax of alendronate.

  4. Time to Maximum Plasma Concentration (Tmax) of Alendronate

    Time frame: At designated timepoints (up to approximately 10 hours post-dose)

    Blood samples will be collected to determine the Tmax of alendronate.

  5. Apparent Terminal Half-Life (t1/2) of Alendronate

    Time frame: At designated timepoints (up to approximately 10 hours post-dose)

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

  6. Apparent Clearance (CL/F) of Alendronate

    Time frame: At designated timepoints (up to approximately 10 hours post-dose)

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

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

    Time frame: At designated timepoints (up to approximately 10 hours post-dose)

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

Secondary outcomes

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

    Time frame: Up to approximately 8 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 3 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 discontinue study treatment due to an AE will be reported.

  3. Total Amount of Alendronate Excreted Unchanged Over a Period of 48 Hours (Ae0-48) after Alendronate Administration

    Time frame: At designated timepoints (up to approximately 48 hours post-dose)

    Urine samples will be collected to determine the Ae0-48 of alendronate.

  4. Maximum Rate (Rmax) of Alendronate Excretion

    Time frame: At designated timepoints (up to approximately 48 hours post-dose)

    Urine samples will be collected to determine the Rmax of alendronate excretion.

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 on the Pharmacokinetics of Alendronate in Healthy Adult Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 14, 2025
Registry last updated
Feb 18, 2025

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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