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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8189-010 | Other Identifier | MSD |
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The purpose of this study is to learn what happens to elpipodect in a healthy person's body over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbon-14 radiolabeled [14C] Elpipodect | Experimental | Participants receive a dose of 4.5-mg immediate release (IR) (~ 50 μCi) orally on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]Elpipodect | Drug | Oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of Elpipodect | Blood samples will be collected to determine the AUC0-24 of elpipodect. | Predose and postdose up to 24 hours |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Elpipodect | Blood samples will be collected to determine the AUClast of elpipodect. | Predose and at designated timepoints up to Day 15 |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Elpipodect | Blood samples will be collected to determine the AUC0-inf of elpipodect. | Predose and at designated timepoints up to Day 15 |
| Maximum Concentration (Cmax) of Elpipodect | Blood samples will be collected to determine the Cmax of elpipodect. | Predose and at designated timepoints up to Day 15 |
| Apparent Half Life (t½) of Elpipodect | Blood samples will be collected to determine the t1/2 of elpipodect. | Predose and at designated timepoints up to Day 15 |
| Time to Reach Maximum Concentration (Tmax) of Elpipodect | Blood samples will be collected to determine the Tmax of elpipodect. | Predose and at designated timepoints up to Day 15 |
| Amount Excreted (Ae) in Urine of Elpipodect | Urine samples will be collected to determine the Ae of elpipodect |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed. |
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Inclusion Criteria:
Key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit Inc. (Site 0001) | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| C000729358 | MK-8189 |
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| Predose and at designated timepoints up to Day 15 |
| %Dose Excreted in Urine of Elpipodect | Urine samples will be collected to determine the %dose of elpipodect | Predose and at designated timepoints up to Day 15 |
| Amount Excreted (Ae) in Feces of Elpipodect | Feces samples will be collected to determine the Ae of elpipodect. | Predose and at designated timepoints up to Day 15 |
| %Dose Excreted in Feces of Elpipodect | Feces samples will be collected to determine the %dose of elpipodect. | Predose and at designated timepoints up to Day 15 |
| Metabolites in Plasma of Elpipodect | Blood samples will be collected to determine the metabolites of elpipodect. | Predose and at designated timepoints up to Day 15 |
| Metabolites in Urine of Elpipodect | Urine samples will be collected to determine the metabolites of elpipodect. | Predose and at designated timepoints up to Day 15 |
| Metabolites in Feces of Elpipodect | Feces samples will be collected to determine the metabolites of elpipodect. | Predose and at designated timepoints up to Day 15 |
| Up to ~ 28 days |
| Number of Participants Discontinuing Study Treatment due to an AE | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed. | Up to ~ 28 days |