Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tedizolid Formulation 1 · 2 trials · 1 indication
Blood samples will be collected to determine the AUC0-Inf of tedizolid.
Blood samples will be collected to determine the AUC0-Last of tedizolid.
Blood samples will be collected to determine the Cmax of tedizolid.
Blood samples will be collected to determine the AUC0-t of tedizolid.
| Arm | Type | Description |
|---|---|---|
| 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). |
| Name | Type | Description |
|---|---|---|
| Tedizolid Phosphate Oral Formulation 1 (Reference) | DRUG | Formulation 1 (FM1) powder for oral suspension. |
| Tedizolid Phosphate Oral Formulation 2 (Test) | DRUG | Formulation 2 (FM2) powder for oral suspension. |
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 Tors...
Tedizolid is an oxazolidinone antibiotic used for bacterial infections, including gram-positive bacterial infections and acute bacterial skin and skin structure infections (ABSSSI). It is being studied for these indications in clinical trials.
Tedizolid is a small molecule antibiotic that targets bacterial protein synthesis. It binds to the 50S ribosomal subunit, inhibiting translation and preventing bacterial growth. This mechanism is effective against gram-positive bacteria, including resistant strains.
Tedizolid is developed by Merck & Company, Inc., which trades under the ticker symbol MRK on the New York Stock Exchange. Merck is conducting clinical trials to evaluate the drug for various bacterial infections.
Tedizolid is in Phase 3 clinical development for bacterial infections. It is an investigational drug and has not been approved by regulatory authorities. Multiple Phase 3 trials have been completed to assess its efficacy and safety.
Tedizolid has been studied in several clinical trials, including NCT02019420 for nosocomial pneumonia, NCT02066402 for ABSSSI, NCT03176134 for pediatric ABSSSI, and NCT03217565 for pharmacokinetics in pediatric gram-positive infections. All trials are completed.
Tedizolid is also known as tedizolid phosphate, which is the prodrug form. The drug is marketed under the brand name Sivextro in some regions. Clinical trials often refer to it as MK-1986 or TR-701 FA.