LEO 32731 SAD/MAD study

• Research type

  Research Study

• Full title

  LEO 32731 - A Phase I, Single-Blind, Placebo Controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects

• IRAS ID

  73476

• Contact name

  Joseph Chiesa

• Sponsor organisation

  LEO Pharma A/S

• Eudract number

  2010-024358-12

• Research summary

  LEO Pharma A/S is currently developing LEO 32731 to treat atopic dermatitis. LEO 32731 inhibits the secretion of tumour necrosis factor-alpha (TNF-a), interferon gamma (IFN-?) and interleukin (IL)-5 but increased the secretion of the anti-inflammatory cytokine, IL-10. The study will be performed in three parts. Part 1 (single ascending dose)In Groups A to D, each subject will participate in one treatment period only. Subjects in Group E will participate in two treatment periods, separated by a minimum of 7 days between each dose administration. In Treatment Period 1, Group E subjects will receive a single dose of LEO 32731 or placebo as an oral solution; in Treatment Period 2 subjects will receive the same dose of LEO 32731 as a solid capsule formulation. During each treatment period, subjects in Groups A to E will reside at the CRU from Day ??1 (the day before dosing) to Day 3 (48 hours post dose), and return on Day 4 (72 hours post dose) for a non-residential visit. Part 2 (effect of Food) In Groups M and N, each subject will participate in two treatment periods, separated by a minimum of 7 days between each dose administration. During each treatment period, subjects will reside at the CRU from Day ??1 (the day before dosing) to Day 3 (48 hours post dose), and return on Day 4 (72 hours post dose) for a non-residential visit. Part 3 (multiple ascending dose) Each subject in Groups X, Y and Z will participate in one treatment period only, residing at the CRU from the evening of Day -1 until the morning of Day 9 (48 hours after the final dose on Day 7). Subjects will return on Day 10 (72 hours after the final dose) for a non-residential visit. All subjects in Parts 1, 2 and 3 will return for a follow-up visit 5 to 7 days after their final dose.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0029

• Date of REC Opinion

  21 Mar 2011

• REC opinion

  Further Information Favourable Opinion