Covance 8239472 Safety,Tolerability and PK of single and multiple dose

• 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

• IRAS ID

  80532

• Sponsor organisation

  ONO Pharma UK Ltd

• Eudract number

  2010-023049-31

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Ono Pharmaceutical Company, Ltd is developing ONO-4053 for use in the treatment of the symptoms of allergic rhinitis. It is hoped that ONO-4053 may reduce the symptoms of allergic rhinitis including nasal congestion in patients who suffer from this condition in the future. This study is designed to assess the safety and tolerability of oral doses of ONO-4053 in healthy adult male and female subjects. The study has been designed to be carried out in a single centre with three separate parts; Part A, Part B and Part C. Part A is designed to enrol 56 healthy male and eight healthy female subjects. Each cohort will have eight subjects, of the first two subjects in the first cohort one subject will be dosed with ONO-4053 and the other will be dosed with placebo, should there be no safety issues observed the further six subjects in the cohort will be dosed the following day with five further subjects receiving ONO-4053 and one further subject receiving placebo. There may be an additional 24 healthy male subjects being added to Part A following agreement from the Safety Review Commitee to receive single, ascending doses of ONO-4053 in a fasted state. Part B will enrol eight healthy male subjects to take part in two treatment periods, in both treatment periods they will each receive a single oral dose of ONO-4053, during the first they will be fasted and in the second the dose will be given following a meal. Part C will enrol up to 32 healthy subjects that will particpate in four cohorts (three cohorts will be male subjects and one cohort will be female) to investigate administration of multiple doses of ONO-4053 following food.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0065

• Date of REC Opinion

  16 Jun 2011

• REC opinion

  Further Information Favourable Opinion