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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1986-043 | 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 absorption and elimination of different oral formulations from the healthy person's body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tedizolid Phosphate Oral Formulation 1 (Reference) | Experimental | Participants receive tedizolid phosphate formulation 1 orally. |
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| Tedizolid Phosphate Oral Formulation 2 (Test) | Experimental | Participants receive tedizolid phosphate formulation 2 orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tedizolid Phosphate Oral Formulation 1 (Reference) | Drug | Oral administration |
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| 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 the Last Measurable Concentration (AUC0-t) of Tedizolid | Blood samples will be collected to determine the AUC0-t 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 |
|---|---|---|
| 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 |
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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 | Oral administration |
|
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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 After Nonintravenous Administration (Vd/F) | Blood samples will be collected to determine the Vd/F of tedizolid. | At designated time points (up to 3 days postdose) |
| Oral 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) |
| 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. | Up to approximately 2 weeks |
| Number of Participants Who Discontinue Study 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. | Up to approximately 2 weeks |