Phase 1 safety, tolerability and PK in healthy Japanese male subjects

• Research type

  Research Study

• Full title

  A phase 1, single centre randomised, double-blind, placebo-controlled, multiple dose trial with incremental dosing to evaluate the safety, tolerability, and pharmacokinetics of oral doses of LEO 32731 in healthy male Japanese subjects.

• IRAS ID

  228349

• Contact name

  Ulrike Lorch

• Contact email

  u.lorch@richmondpharmacology.com

• Sponsor organisation

  LEO Pharma A/S

• Eudract number

  2017-000907-26

• Duration of Study in the UK

  0 years, 1 months, 13 days

• Research summary

  LEO 32731 is an investigational drug (IMP) being developed for the treatment for psoriasis.
  The trial will comprise of 10 healthy male Japanese volunteers between the ages of 20 and 45 years. Volunteers will be randomised to receive either active drug or placebo (4:1 ratio) via oral administration, subject to inclusion and exclusion criteria assessed at both screening and day-1. The trial will be conducted in a double-blind manner throughout.
  This trial will investigate the safety, tolerability and how long LEO 32731 stays in the body (Pharmacokinetic [PK] parameters) in healthy male Japanese volunteers after oral administration. The primary objective will be assessment of PK data. Primary endpoints are PK parameters (AUC, Cmax and Tmax) of LEO 32731 at day 12. Data obtained from this trial will bridge existing data from the other Phase 1 trials, to support the inclusion of Japanese patients into Phase 2b trials.
  Volunteers will be resident in the clinical trials unit for 15 nights (day-1 to day 15). Dosing will take place over 12 sequential days with each volunteer being dosed twice a day with either active drug or placebo on day one through to day 11, and will receive a morning dose only on day 12. The dose level will be increased at pre-determined increments to enhance tolerability while progressing to the maximum dosing of 30 mg from day seven. This will ultimately allow measurement of PK, and safety and tolerability assessments at that maximum dose level. The dosing regimen will take place as follows; 10 mg given twice a day for three days, 20 mg given twice a day for three days, 30 mg given twice a day for five days, and a final 30 mg dose for one day.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  17/LO/0860

• Date of REC Opinion

  27 Jul 2017

• REC opinion

  Further Information Favourable Opinion