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

NCTNCT06772792Other id0616-027Other idMK-0616-027

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 36 participants (actual)
Sponsor: Merck Sharp & Dohme LLC · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 23 Apr 2024
Primary completion: 21 Jun 2024
Completion: 21 Jun 2024
First posted: 14 Jan 2025
Last update posted: 18 Feb 2025
Conditions: Healthy

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20242025

Ph 1
A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Alendronate in Healthy Adult Participants (MK-0616-027)
NCT06772792
23 Apr 2024 to 21 Jun 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

AlendronateDrug
Enlicitide DecanoateDrug

Arms2

Experimental
Alendronate
Participants receive a single oral dose of alendronate on Day 1 OR participants receive a single oral dose of alendronate on Day 15 depending on randomization.
Experimental
Alendronate + Enlicitide Decanoate
Participants receive an oral dose of alendronate plus an oral dose of enlicitide decanoate on Day 1 OR participants receive an oral dose of alendronate plus an oral dose of enlicitide decanoate on Day 15 depending on randomization.

Primary outcomes7

Outcomes the sponsor listed as primary.

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)
Registry description
Blood samples will be collected to determine the AUC0-Last of alendronate.
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)
Registry description
Blood samples will be collected to determine the AUC0-Inf of alendronate.
Maximum Plasma Concentration (Cmax) of Alendronate
Time frame · At designated timepoints (up to approximately 10 hours post-dose)
Registry description
Blood samples will be collected to determine the Cmax of alendronate.
Time to Maximum Plasma Concentration (Tmax) of Alendronate
Time frame · At designated timepoints (up to approximately 10 hours post-dose)
Registry description
Blood samples will be collected to determine the Tmax of alendronate.
Apparent Terminal Half-Life (t1/2) of Alendronate
Time frame · At designated timepoints (up to approximately 10 hours post-dose)
Registry description
Blood samples will be collected to determine the t1/2 of alendronate.
Apparent Clearance (CL/F) of Alendronate
Time frame · At designated timepoints (up to approximately 10 hours post-dose)
Registry description
Blood samples will be collected to determine the CL/F of alendronate.
Apparent Volume of Distribution (Vz/F) of Alendronate
Time frame · At designated timepoints (up to approximately 10 hours post-dose)
Registry description
Blood samples will be collected to determine Vz/F of alendronate.

Secondary outcomes(4)

Number of Participants Who Experience an Adverse Event (AE)
Time frame · Up to approximately 8 weeks
Registry description
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
Time frame · Up to approximately 3 weeks
Registry description
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.
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)
Registry description
Urine samples will be collected to determine the Ae0-48 of alendronate.
Maximum Rate (Rmax) of Alendronate Excretion
Time frame · At designated timepoints (up to approximately 48 hours post-dose)
Registry description
Urine samples will be collected to determine the Rmax of alendronate excretion.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 19 Years up to 55 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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