Single Dose PK of IV Tedizolid Phosphate in Morbidly Obese and Non-Obese Adults
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open label, single-dose, pharmacokinetic study in 9 obese and 9 age-, sex-, ideal
      body weight- matched non-obese subjects. Qualifying subjects who have completed an informed
      consent will receive a single intravenous dose of tedizolid with the collection of 11 blood
      samples over 72 hours post dose.
    

Detailed description: 
      Subjects will present to the clinical research unit in the morning (approximately 6:30 a.m.)
      of the dosing day. A urine pregnancy test will be performed to rule out pregnancy prior to
      administration of the tedizolid phosphate dose to female subjects. The subject's height,
      total body weight, and vital signs (heart rate, blood pressure, temperature, and respiratory
      rate) will be recorded. Subjects judged (by study physician) to be healthy enough to
      participate will proceed with the study procedures.

      An 18-20 gauge intravenous peripheral catheter will be inserted into the antecubital vein or
      a vein in the fore-arm of the non-dominant arm for sequential blood sampling, and an initial
      predose blood sample (5 mL) will be collected. A minimum of 3-5 mL of blood is required per
      pharmacokinetic sampling time-point. Each blood collection tube will be pre-labeled with: 1.)
      study protocol number; 2.) subject study number; 3.) date of collection; 4.) time-point. A
      0.9% Sodium Chloride infusion may be run through the peripheral line at 30 to 40 mL per hour
      to maintain catheter patency for the 12 hour sampling phase. Alternatively, a heparin lock
      technique will be utilized to maintain intravascular catheter patency.

      A single-dose of tedizolid phosphate will be administered as an intravenous infusion (250 mL
      normal saline) over 1 hour (~8:00 a.m.). The intravenous administration tubing will be
      flushed with 0.9% Sodium Chloride infusion at 250 mL per hour (to match the tedizolid
      phosphate rate of infusion) for 10 minutes to ensure complete dose delivery. Blood samples (5
      mL) will be collected 0.5 (middle of infusion), 1 (end of infusion), 2, 4, 6, 8, 12, 24, 48,
      and 72 hours post dose in blood collection tubes. The plasma will be harvested
      (centrifugation at 4°C) within 60 minutes of collection and stored at -70°C as two aliquots
      until analysis. The intravascular catheter "dead-space" volume will be discarded prior to
      blood sample collection by withdrawing 1.5-2 mL from the catheter to ensure no unintentional
      sample dilution. The intravascular catheter will be removed after the 12 hour sample and the
      subject will be discharged from the research unit. The subject will return to the research
      unit for blood sample collection on a daily basis at the following points: 24 (Visit 3), 48
      (Visit 4), and 72 hours (Visit 5) after the dose via a peripheral vein needle stick. The
      exact date and time of blood sample collection will be recorded on case report forms. Each
      blood sample tube will be inverted and made up-right 5 times to afford mixing of blood with
      the anticoagulant. Blood samples will be maintained on wet ice and centrifuged at 1200 g for
      10 minutes at 4°C within 60 minutes of collection to yield approximately 2 mL of plasma per 5
      mL blood collection. The plasma samples will be transferred from the -20°C freezer for
      storage at -70°C at the end of the sample collection period until analysis.
    

Intervention name(s): Tedizolid phosphate
Intervention type(s): Drug
Intervention description(s): Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
Other intervention name(s): Sivextro
Intervention MeSH terms: Tedizolid; Tedizolid phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research