Phase 1, TP-434, multiple ascending oral doses in healthy volunteers

• Research type

  Research Study

• Full title

  Phase 1 Single-Center, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of TP-434 Administered as Multiple-Ascending Oral Doses to Healthy Male and Female Subjects

• IRAS ID

  68908

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Tetraphase, Inc.

• Eudract number

  2010-023932-17

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  As a result of its novel structural characteristics, TP-434 exhibits potent activity against tetracycline-resistant strains of both gram-positive and gram-negative bacteria and is not susceptible to resistant mechanisms specific for other antibiotic classes. Pathogen coverage includes problematic multidrug-resistant and methicillin-resistant Staphylococcus aureus, streptococci, enterococci, Enterobacteriaceae strains that are carbapenem-resistant and/or are producing extended-spectrum Ç?-lactamases (ESÇ?L), Proteeae and Acinetobacter. The antibacterial coverage of TP-434 is broader than quinolones, cephalosporins, or carbapenems, with the exception of lower potency against Pseudomonas aeruginosa strains. TP-434 has MIC90 values of =0.5, =1, and =2 æg/ml against a wide range of gram-positive bacteria, anaerobes, and gram-negative pathogens, respectively. The purpose of this study is to determine the potential utility of oral dosing of TP-434.

• REC name

  Wales REC 2

• REC reference

  10/WSE02/72

• Date of REC Opinion

  9 Dec 2010

• REC opinion

  Favourable Opinion