FIH PK and PD of SAD and MAD, and Food Effect in Healthy Subjects

• Research type

  Research Study

• Full title

  A first-in-human, double-blind, randomised, placebo-controlled Phase I study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of PRX167700 in healthy male subjects; and the effect of food on the pharmacokinetics of a single oral dose of PRX167700 in healthy male subjects.

• IRAS ID

  90699

• Contact name

  John Lambert

• Sponsor organisation

  Proximagen Limited

• Eudract number

  2011-005326-21

• Research summary

  PRX167700 is a small molecule inhibitor of semicarbazide sensitive amine oxide and is currently being developed for the treatment of chronic inflammatory diseases including rheumatoid arthritis. The purpose of this first-in-human (FIH) study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of PRX167700 in healthy male subjects. This study will be divided into two parts. Part A will include the single ascending dose (SAD) cohorts and a food effect cohort, and Part B will include the multiple ascending dose (MAD) cohorts.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0185

• Date of REC Opinion

  16 Jan 2012

• REC opinion

  Further Information Favourable Opinion