Safety & blood levels of single & repeated doses of ONO-4053; ver 1

• Research type

  Research Study

• Full title

  A phase 1, single centre, three-part, randomised, study to investigate the safety, tolerability and pharmacokinetic profile of single and multiple ascending doses of oral ONO-4053 and the effects of food on this profile in healthy male and female subjects (HMR code 11-024)

• IRAS ID

  94823

• Contact name

  Steve Warrington

• Sponsor organisation

  Ono Pharma UK Ltd

• Eudract number

  2011-005365-21

• ISRCTN Number

  xxx

• Research summary

  The study medicine (ONO-4053) is an experimental new medicine for hay fever and other forms of allergy that affect the nose. We'll test single and repeated doses of ONO-4053, to find out its side effects and blood levels, and to see if food affects absorption of the medicine into the bloodstream. If participants consent, We'll also study how their genes (pieces of DNA) affect how the body responds to or handles ONO-4053. The study will be in 3 parts, in healthy men and women aged 18??45 years. In Part A, We'll test single doses in up to 64 men and 8 women. Participants will stay on the ward for 4 nights and make 2 outpatient visits. They??ll take up to 5 weeks to finish the study. In Part B, test 2 single doses in 8 healthy men: one dose after an overnight fast, and the other after a high-fat breakfast. Participants will have 2 study sessions (they??ll stay on the ward for 4 nights in each session), and make 2 outpatient visits. They??ll take up to 6 weeks to finish the study. In Part C, We'll give up to 32 men and 8 women repeated doses for up to 14 days. Participants will stay on the ward for up to 17 nights and make 2 outpatient visits. They??ll take up to 7 weeks to finish the study. In Parts A and C, We'll start with low doses and increase the dose as the study progresses. In Parts A and C, some participants will take dummy medicine. A pharmaceutical company (Ono Pharmaceutical Co Ltd) is paying for the study. The study will take place at 1 centre in London. We'll recruit healthy participants by: advertising (newspaper, radio, and websites); word of mouth; from volunteer databases; and via our websites.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  11/LO/1977

• Date of REC Opinion

  21 Dec 2011

• REC opinion

  Favourable Opinion