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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7962-027 | Other Identifier | MSD |
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The goal of the study is to learn what happens to different forms of sotatercept medications in a healthy person's body over time. Researchers want to know if there is a difference in the healthy person's body when different forms of sotatercept medications are given.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose Subcutaneous Injection | Active Comparator | Participants will receive a single subcutaneous high dose of sotatercept administered via syringe. |
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| High Dose Subcutaneous Autoinjector | Experimental | Participants will receive a single subcutaneous high dose of sotatercept administered via autoinjector. |
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| Low Dose Subcutaneous Autoinjector | Experimental | Participants will receive a single subcutaneous low dose of sotatercept administered via autoinjector. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotatercept | Biological | Subcutaneous Injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Sotatercept at High Dose | Blood samples will be collected to determine the AUC0-inf of sotatercept in plasma. | Predose and at designated timepoints (up to approximately 120 days postdose) |
| Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Sotatercept at High Dose | Blood samples will be collected to determine the AUC0-last of sotatercept in plasma. | Predose and at designated timepoints (up to approximately 120 days postdose |
| Maximum Observed Concentration (Cmax) of Sotatercept at High Dose | Blood samples will be collected to determine the Cmax of sotatercept in plasma. | Predose and at designated timepoints (up to approximately 120 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Time of the Maximum Observed Concentration (Tmax) of Sotatercept High Dose | Blood samples will be collected to determine the Tmax of sotatercept in plasma. | Predose and at designated timepoints (up to approximately 120 days postdose |
| Apparent Terminal Elimination Half-Life (t1/2) of Sotatercept at High Dose |
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Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Is in good health before randomization
Has a body weight between 75 and 100 kg, inclusive
Is assigned female sex at birth and is a participant of nonchildbearing potential (PONCBP) defined as one of 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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials ( Site 0007) | Anaheim | California | 92801 | United States | ||
| Advanced Pharma CR, LLC ( Site 0005) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Sotatercept Autoinjector | Biological | Subcutaneous Auto Injection |
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Blood samples will be collected to determine the t1/2 of sotatercept in plasma. |
| Predose and at designated timepoints (up to approximately 120 days postdose |
| Apparent Total Plasma Clearance (CL/F) of Sotatercept at High Dose | Blood samples will be collected to determine the CL/F of sotatercept in plasma. | Predose and at designated timepoints (up to approximately 120 days postdose |
| Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Sotatercept at High Dose | Blood samples will be collected to determine the Vz/F of sotatercept in plasma. | Predose and at designated timepoints (up to approximately 120 days postdose |
| Cmax of Sotatercept Low Dose | Blood samples will be collected to determine the Cmax of sotatercept in plasma. | Predose and at designated timepoints (up to approximately 120 days postdose |
| Tmax of Sotatercept at Low Dose | Blood samples will be collected to determine the Tmax of sotatercept in plasma. | Predose and at designated timepoints (up to approximately 120 days postdose |
| AUC0-inf of Sotatercept at Low Dose | Blood samples will be collected to determine the AUC0-inf of sotatercept in plasma. | Predose and at designated timepoints (up to approximately 120 days postdose |
| AUC0-last of Sotatercept at Low Dose | Blood samples will be collected to determine the AUC0-last of sotatercept in plasma. | Predose and at designated timepoints (up to approximately 120 days postdose |
| t1/2 of Sotatercept at Low Dose | Blood samples will be collected to determine the t1/2 of sotatercept in plasma. | Predose and at designated timepoints (up to approximately 120 days postdose |
| CL/F of Sotatercept at Low Dose | Blood samples will be collected to determine the CL/F of sotatercept in plasma. | Predose and at designated timepoints (up to approximately 120 days postdose |
| Vz/F of Sotatercept at Low Dose | Blood samples will be collected to determine the Vz/F of sotatercept in plasma. | Predose and at designated timepoints (up to approximately 120 days postdose |
| Number of Participants who Experienced an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. | Up to approximately 120 days |
| Number of Participants who Discontinued the Study Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. | Up to approximately 120 days |
| Miami |
| Florida |
| 33147 |
| United States |
| QPS-MRA, LLC ( Site 0004) | South Miami | Florida | 33143 | United States |
| Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0003) | Springfield | Missouri | 65802 | United States |
| ID | Term |
|---|---|
| C542017 | ACE-011 |
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