PK of TP-434 as novel oral formulations in HVs (QBR113360)

• Research type

  Research Study

• Full title

  Study to Investigate the Pharmacokinetics of TP-434 when Administered as Novel Oral Formulations in Healthy Volunteers

• IRAS ID

  110011

• Contact name

  Stuart Mair

• Sponsor organisation

  Tetraphase Pharmaceuticals, Inc.

• Eudract number

  2012-002336-89

• Research summary

  The Sponsor is developing the study drug, TP-434, as a highly effective antibiotic for potential use against a broad spectrum of pathogens.The study will try to identify the pharmacokinetics of novel oral formulations of the study drug, using a reference product as a comparator.This study will dose TP-434 at 100 mg in a 4-way crossover design to a single cohort of healthy male and female subjects. In Regimen A the subjects will be dosed with the reference immediate release capsule; in Regimen B they will be dosed with an immediate release capsule plus dextrare (Emdex©); in Regimen C they will be dosed with an immediate release capsule plus Gelucire© 44/14; and in Regimen D they will be dosed with an immediate release tablet. All subjects will receive the reference product in Period 1, after which the remaining regimens will be given in an unfixed order.

• REC name

  HSC REC B

• REC reference

  12/NI/0102

• Date of REC Opinion

  30 Jul 2012

• REC opinion

  Further Information Favourable Opinion