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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7240-009 | Other Identifier | MSD |
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The goal of this study is to learn what happens to MK-7240 in a healthy person's body over time (pharmacokinetic or PK study). Researchers also want to learn about the safety of MK-7240 and if people tolerate it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Tulisokibart Form 1 | Experimental | Participants will receive tulisokibart form 1. |
|
| Arm 2: Tulisokibart Form 2 | Experimental | Participants will receive tulisokibart form 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tulisokibart Form 1 | Biological | Solution for injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tulisokibart | Blood samples will be collected to determine the AUC0-inf of tulisokibart. | At designated timepoints up to 14 weeks |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tulisokibart | Blood samples will be collected to determine the AUC0-last of tulisokibart. | At designated timepoints up to 14 weeks |
| Maximum Plasma Concentration (Cmax) of Tulisokibart | Blood samples will be collected to determine the Cmax of tulisokibart. | At designated timepoints up to 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | At designated timepoints up to 14 weeks |
| Number of Participants Who Discontinue Study Due to an AE |
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Inclusion Criteria
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria
The main 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 |
|---|---|---|---|---|---|---|
| Nucleus Network ( Site 0002) | Brisbane | Queensland | 4006 | Australia | ||
| Nucleus Network ( Site 0001) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Tulisokibart Form 2 | Biological | Solution for injection. |
|
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| At designated timepoints up to 14 weeks |
| Time to Maximum Plasma Concentration (Tmax) of Tulisokibart | Blood samples will be collected to determine the Tmax of tulisokibart. | At designated timepoints up to 14 weeks |
| Apparent Clearance (CL/F) of Tulisokibart | Blood samples will be collected to determine the CL/F of tulisokibart. | At designated timepoints up to 14 weeks |
| Apparent Volume of Distribution (V/F) of Tulisokibart | Blood samples will be collected to determine the V/F of tulisokibart. | At designated timepoints up to 14 weeks |
| Apparent Terminal Half-life (t1/2) of Tulisokibart | Blood samples will be collected to determine the t1/2 of tulisokibart. | At designated timepoints up to 14 weeks |
| Apparent Terminal Elimination Rate constant (Kel) of Tulisokibart | Blood samples will be collected to determine the Kel of tulisokibart. | At designated timepoints up to 14 weeks |
| Ratio of AUC0-Last/AUC0-Inf of Tulisokibart | Blood samples will be collected to determine the ratio of AUC0-last/AUC0-inf of tulisokibart. | At designated timepoints up to 14 weeks |
| Area Under the Concentration-Time Curve from Time 0 to Day 14 (pAUC0-14) of Tulisokibart | Blood samples will be collected to determine pAUC0-14 of tulisokibart. | At designated timepoints up to 14 days |
| Melbourne |
| Victoria |
| 3004 |
| Australia |