A Study to Evaluate the Definitive Bioequivalence of Tedizolid Phosphate Single-Unit-Dose Sachet Powder for Oral Suspension Compared to Tedizolid Phosphate Powder for Oral Suspension Bottle Used in Pediatric Clinical Studies
Overview
- Phase
- Phase 1
- Intervention
- Tedizolid Phosphate Oral Formulation 1 (Reference)
- Conditions
- Healthy
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tedizolid
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The key inclusion criteria include but are not limited to the following:
- •Has body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2
Exclusion Criteria
- •The key exclusion criteria include but are not limited to the following:
- •Has a history of or presence of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of long QT syndrome), or uncorrected hypokalemia or hypomagnesemia
- •Has a history of clostridium difficile-associated diarrhea
Arms & Interventions
Tedizolid Phosphate Oral Formulation 1 (Reference)
Participants will receive oral Formulation 1 (Reference).
Intervention: Tedizolid Phosphate Oral Formulation 1 (Reference)
Tedizolid Phosphate Oral Formulation 2 (Test)
Participants will receive oral Formulation 2 (Test).
Intervention: Tedizolid Phosphate Oral Formulation 2 (Test)
Outcomes
Primary Outcomes
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tedizolid
Time Frame: At designated time points (up to 3 days postdose)
Blood samples will be collected to determine the AUC0-Inf of tedizolid.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tedizolid
Time Frame: At designated time points (up to 3 days postdose)
Blood samples will be collected to determine the AUC0-Last of tedizolid.
Maximum Plasma Concentration (Cmax) of Tedizolid
Time Frame: At designated time points (up to 3 days postdose)
Blood samples will be collected to determine the Cmax of tedizolid.
Secondary Outcomes
- Number of Participants Who Experienced an Adverse Event (AE)(Up to approximately 2 weeks postdose)
- Number of Participants Who Discontinue Study Drug Due to an AE(Up to approximately 2 weeks postdose)
- Time to Maximum Plasma Concentration (Tmax) of Tedizolid(At designated time points (up to 3 days postdose))
- Apparent Terminal Half-Life (t1/2) of Tedizolid(At designated time points (up to 3 days postdose))
- Apparent Volume of Distribution of Tedizolid During Terminal Phase (Vz/F)(At designated time points (up to 3 days postdose))
- Apparent Clearance (CL/F) of Tedizolid(At designated time points (up to 3 days postdose))