An Investigation of OC000459 in healthy volunteers

• Research type

  Research Study

• Full title

  AN EVALUATION OF THE PLASMA AND URINE PHARMACOKINETICS OF THE ACYLGLUCURONIDE METABOLITE OF OC000459 IN HEALTHY MALE AND FEMALE SUBJECTS

• IRAS ID

  171410

• Contact name

  K M Donaldson

• Sponsor organisation

  Atopix Therapeutics Ltd

• Eudract number

  2014-005488-33

• Duration of Study in the UK

  0 years, 1 months, 13 days

• Research summary

  This study is investigating a drug called OC000459. A pharmaceutical company called Atopix Therapeutics is developing OC000459 as a once-a-day oral treatment for conditions such as asthma, atopic dermatitis (eczema) and hay fever.

  When medicines are taken they can be broken down by the body into by-products or metabolites. A major metabolite of OC000459 is called acylglucuronide. The purpose of this study is to determine how much of the parent compound OC000459 and acylglucuronide are present after taking OC000459 once-a-day for 8 days.

  This study will involve 18 subjects (half males and half females). The study visits include:

  • A screening visit
  • One treatment period of approximately 14 days in duration (This includes 3 overnight stays(from the afternoon of Day 7 until the morning of Day 10)).
  • An end of study visit 11-15 days following last dose.

  The population eligible to take part in the study includes healthy male and female subjects age 18 to 55 years, in good health as determined by past medical history, physical examination, vital signs and laboratory tests completed during screening at Simbec.

• REC name

  Wales REC 1

• REC reference

  15/WA/0014

• Date of REC Opinion

  4 Feb 2015

• REC opinion

  Favourable Opinion