A Single-Dose, Randomized, Placebo- and Active-Control, Four-Way, Cross-Over Study for the Evaluation of the Effect of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) on the QT/QTc Intervals in Adult Healthy Subjects
Condition: TQT Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind (with respect to Tebipenem pivoxil hydrobromide
      [TBPM-PI-HBr]/placebo only), placebo- and active-control, single-dose, 4-way crossover study
      that will enroll 24 healthy adult male and female subjects. There will be a washout period of
      at least 7 days between dosing in each period and each subject will receive all 4 treatments
      over 4 periods in a crossover study design.
    

Detailed description: 
      This is a randomized, double-blind (with respect to TBPM-PI-HBr / placebo only), placebo- and
      active-control, single-dose, 4-way crossover study. Twenty-four (24) healthy, adult, male and
      female subjects will be enrolled. Screening of subjects will occur within 28 days prior to
      the first dosing.

      All subjects will receive a single dose of 4 different study treatments over 4 separate
      treatment periods, each separated by a 7-day washout period.

      On Day 1 of Period 1, subjects will be randomized to 1 of 12 treatment sequences. Sentinel
      group: In Period 1 only, 4 subjects will be dosed 24 hours prior to the remaining 20
      subjects. Each of the 4 subjects from the sentinel group will receive a different treatment.

      On Day 1 of each period, subjects will receive a single oral therapeutic dose of TBPM-PI-HBr
      (Treatment A), supratherapeutic dose of TBPM-PI-HBr (Treatment B), placebo (Treatment C), or
      moxifloxacin (Treatment D) according to the randomization scheme.

      In each period, cardiodynamic ECGs and PK blood samples will be collected pre-dose and for 24
      hours post-dose. Safety will be monitored throughout the study by repeated clinical and
      laboratory evaluations.

      Discontinued subjects who have received study drug will not be replaced.
    

Intervention name(s): Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + Placebo; Moxifloxacin 400mg; Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr); Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): Treatment A: Subjects receive TBPM-PI-HBr + matching Placebo.; Treatment D: Subjects receive 1 400 mg tablet of moxifloxacin administered in an open label manner.; Treatment C: Subjects receive TBPM-PI-HBr matching placebo.; Treatment B: Subjects receive TBPM-PI-HBr.
Other intervention name(s): SPR994; Avelox; SPR994
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Over 4 separate treatment periods, each separated by a 7-day washout period, all subjects will receive a single dose of 4 different study treatments.The design is constructed from three 4x4 Latin Squares balanced for carry-over effects.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: TQT