A Study to Compare Oral Formulations of Tedizolid Phosphate in Healthy Adults (MK-1986-044)
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT06609161
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Tedizolid Phosphate Oral Formulation 1 (Reference) Tedizolid Phosphate Oral Formulation 1 (Reference) Participants will receive oral Formulation 1 (Reference). Tedizolid Phosphate Oral Formulation 2 (Test) Tedizolid Phosphate Oral Formulation 2 (Test) Participants will receive oral Formulation 2 (Test).
- Primary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tedizolid 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 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 At designated time points (up to 3 days postdose) Blood samples will be collected to determine the Cmax of tedizolid.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Experienced an Adverse Event (AE) Up to approximately 2 weeks postdose An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Number of Participants Who Discontinue Study Drug Due to an AE Up to approximately 2 weeks postdose An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Time to Maximum Plasma Concentration (Tmax) of Tedizolid At designated time points (up to 3 days postdose) Blood samples will be collected to determine the Tmax of tedizolid.
Apparent Terminal Half-Life (t1/2) of Tedizolid At designated time points (up to 3 days postdose) Blood samples will be collected to determine the t1/2 of tedizolid.
Apparent Volume of Distribution of Tedizolid During Terminal Phase (Vz/F) At designated time points (up to 3 days postdose) Blood samples will be collected to determine the Vz/F of tedizolid.
Apparent Clearance (CL/F) of Tedizolid At designated time points (up to 3 days postdose) Blood samples will be collected to determine the CL/F of tedizolid.
Trial Locations
- Locations (1)
Celerion (Site 0001)
🇺🇸Lincoln, Nebraska, United States