Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA)
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      single rising and multiple rising IV doses of TR-701 FA and to determine the absolute
      bioavailability of oral TR-701 FA following single oral and IV dose administrations in
      healthy adult subjects.
    

Detailed description: 
      SAD/Part A.

        -  All subjects in the Pilot Cohort will receive a single infusion of 50 mg TR-701 FA for
           injection in 250 cc of saline over 180 minutes.

        -  Subjects in Cohort 1 will be randomized to receive a single infusion of placebo or 100
           mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.

        -  Subjects in Cohort 2 will be randomized to receive a single infusion of placebo or 200
           mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.

        -  Subjects in Cohort 3 will be randomized to receive a single infusion of placebo or 400
           mg of TR-701 FA for injection in 250 or 500 cc of saline over 60 or 120 minutes.

      MAD/Part B

        -  Subjects in Cohort 4 will be randomized to receive once daily infusions of placebo or
           200 mg of TR-701 FA for injection in 250 cc of saline over 60 minutes for 7 days.

        -  Subjects in Cohort 5 will be randomized to receive once daily infusions of placebo or
           300 mg of TR-701 FA for injection in 250 cc of saline over 60 minutes for 7 days.

      BA/Part C

        -  Subjects in Cohort 6 will receive a single 60 minute infusion of 200 mg TR-701 FA for
           injection in 250 cc of saline and a singe oral dose of 200 mg TR-701 FA tablet in an
           open-label crossover design.

      Venous Tolerability/Part D

      - Subjects in Cohort 8 will receive once daily 60 minute infusions of 200 mg TR-701 FA for
      injection in 250 cc of saline for 3 days and once daily placebo infusions for 3 daysin a
      blinded crossover design.
    

Intervention name(s): TR-701 FA for injection, 200 mg/vial; TR-701 FA tablets
Intervention type(s): Drug; Drug
Intervention description(s): TR-701 FA for injection will be given as a single infusion at doses of 50 mg, 100 mg, 200 mg, and 400 mg in SAD/Part A (Pilot and Cohorts 1 to 3). TR-701 FA for injection will be given as once daily infusions at doses of 200 mg and 400 mg for 7 days in MAD/Part B (Cohorts 4 & 5). TR-701 FA for injection will be given once as a 200 mg IV infusion in BA/Part C (Cohort 6). TR-701 FA 200 mg will be given daily for 3 days in Venous Tolerability/Part D; TR-701 FA will be given once orally as a 200 mg tablet in Part C.
Other intervention name(s): Torezolid Phospate; Torezolid Phosphate Tablet
Intervention MeSH terms: Tedizolid phosphate; Tedizolid; Oxazolidinones
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science