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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0616-027 | Other Identifier | MSD |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alendronate | Experimental | 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. |
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| Alendronate + Enlicitide Decanoate | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alendronate | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Alendronate | Blood samples will be collected to determine the AUC0-Last of alendronate. | At designated timepoints (up to approximately 10 hours post-dose) |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Alendronate | Blood samples will be collected to determine the AUC0-Inf of alendronate. | At designated timepoints (up to approximately 10 hours post-dose) |
| Maximum Plasma Concentration (Cmax) of Alendronate | Blood samples will be collected to determine the Cmax of alendronate. | At designated timepoints (up to approximately 10 hours post-dose) |
| Time to Maximum Plasma Concentration (Tmax) of Alendronate | Blood samples will be collected to determine the Tmax of alendronate. | At designated timepoints (up to approximately 10 hours post-dose) |
| Apparent Terminal Half-Life (t1/2) of Alendronate | Blood samples will be collected to determine the t1/2 of alendronate. | At designated timepoints (up to approximately 10 hours post-dose) |
| Apparent Clearance (CL/F) of Alendronate | Blood samples will be collected to determine the CL/F of alendronate. | At designated timepoints (up to approximately 10 hours post-dose) |
| Apparent Volume of Distribution (Vz/F) of Alendronate |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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. | Up to approximately 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion (Site 0001) | Lincoln | Nebraska | 68502 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Enlicitide Decanoate | Drug | Oral administration |
|
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Blood samples will be collected to determine Vz/F of alendronate. |
| At designated timepoints (up to approximately 10 hours post-dose) |
| Number of Participants Who Discontinue Study Treatment Due to an AE |
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. |
| Up to approximately 3 weeks |
| Total Amount of Alendronate Excreted Unchanged Over a Period of 48 Hours (Ae0-48) after Alendronate Administration | Urine samples will be collected to determine the Ae0-48 of alendronate. | At designated timepoints (up to approximately 48 hours post-dose) |
| Maximum Rate (Rmax) of Alendronate Excretion | Urine samples will be collected to determine the Rmax of alendronate excretion. | At designated timepoints (up to approximately 48 hours post-dose) |
| ID | Term |
|---|---|
| D019386 | Alendronate |
| C000728674 | MK-0616 |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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