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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1986-044 | Other Identifier | MSD |
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The goal of the study is to learn what happens to different oral formulations of tedizolid phosphate (MK-1986) in a healthy person's body over time. Researchers want to know if there is a difference in the oral formulations absorption and elimination from the healthy persons body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tedizolid Phosphate Oral Formulation 1 (Reference) | Experimental | Participants will receive oral Formulation 1 (Reference). |
|
| Tedizolid Phosphate Oral Formulation 2 (Test) | Experimental | Participants will receive oral Formulation 2 (Test). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tedizolid Phosphate Oral Formulation 1 (Reference) | Drug | Formulation 1 (FM1) powder for oral suspension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tedizolid | Blood samples will be collected to determine the AUC0-Inf of tedizolid. | At designated time points (up to 3 days postdose) |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tedizolid | Blood samples will be collected to determine the AUC0-Last of tedizolid. | At designated time points (up to 3 days postdose) |
| Maximum Plasma Concentration (Cmax) of Tedizolid | Blood samples will be collected to determine the Cmax of tedizolid. | At designated time points (up to 3 days postdose) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. | Up to approximately 2 weeks postdose |
| Number of Participants Who Discontinue Study Drug Due to an AE |
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Inclusion Criteria:
The 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 |
|---|---|---|---|---|---|---|
| Celerion (Site 0001) | Lincoln | Nebraska | 68502 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Tedizolid Phosphate Oral Formulation 2 (Test) | Drug | Formulation 2 (FM2) powder for oral suspension. |
|
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. |
| Up to approximately 2 weeks postdose |
| Time to Maximum Plasma Concentration (Tmax) of Tedizolid | Blood samples will be collected to determine the Tmax of tedizolid. | At designated time points (up to 3 days postdose) |
| Apparent Terminal Half-Life (t1/2) of Tedizolid | Blood samples will be collected to determine the t1/2 of tedizolid. | At designated time points (up to 3 days postdose) |
| Apparent Volume of Distribution of Tedizolid During Terminal Phase (Vz/F) | Blood samples will be collected to determine the Vz/F of tedizolid. | At designated time points (up to 3 days postdose) |
| Apparent Clearance (CL/F) of Tedizolid | Blood samples will be collected to determine the CL/F of tedizolid. | At designated time points (up to 3 days postdose) |