Phase 1 TP-2758 multiple ascending doses, healthy volunteers

• Research type

  Research Study

• Full title

  A Phase 1, Randomized, Placebo-Controlled, Single-Blind, Multiple-Dose, Dose-Escalation Clinical Study to Assess the Safety and Pharmacokinetics of TP-2758 in Normal Healthy Volunteers

• IRAS ID

  75064

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Tetraphase Pharmaceuticals, Inc.

• Eudract number

  2011-001204-35

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The TP-2758-001-P1-FIM study is designed to examine the safety, tolerability and pharmacokinetics of TP-2758 in a capsule formulation for oral administration in healthy adult subjects after a single dose and once daily dosing for 7 consecutive days. The study is further designed to characterize the pharmacokinetic profile of TP-2758 and its elimination into urine after single dose administrations in healthy subjects in both the fasted and fed states. Future clinical development of TP-2758 will focus on treatment of serious bacterial infections using clinical and microbiological cure as measures of efficacy. The current Investigator's Brochure outlines non-clinical studies carried out with TP-2758. Once completely developed, TP-2758 may provide an effective therapy for the treatment of bacterial infections.

• REC name

  Wales REC 2

• REC reference

  11/WA/0069

• Date of REC Opinion

  15 Apr 2011

• REC opinion

  Favourable Opinion