Evaluation of the safety & tolerability XEN-D0103 in healthy subjects

• Research type

  Research Study

• Full title

  A Single Centre, Randomised, Double-blind, Placebo-controlled, Fed fasted, Single and Multiple Ascending Dose Trial of XEN-D0103 in Healthy Subjects

• IRAS ID

  80540

• Sponsor organisation

  Xention Ltd

• Eudract number

  2011-001070-25

• Research summary

  This study is an evaluation of the safety and tolerability of XEN-D0103 in healthy subjects. The investigational study drug XEN-D0103, is being developed by the sponsor, Xention Ltd as an intended treatment for abnormal heart rhythm called atrial fibrillation. This study will be the first time XEN-D0103 is administered to humans. The aim of the study is to assess the effects of a capsule formulation of XEN-D0103 in 3 parts. Part 1 will assess the safety, tolerability and blood levels of the ascending single doses of XEN-D0103. In Part 2, blood levels of XEN-D0103 will be assessed when administered with food and also without food. In Part 3, the safety, tolerability and blood levels of XEN-D0103 will be assessed following dosing for 10 days.PART 1: Up to 8 groups of 8 male subjects may be enrolled. In each group 6 subjects will receive a single oral dose of XEN-D0103 and 2 will receive placebo (a dummy treatment). The treatments will be randomly allocated to the volunteers. The dose will be increased with each cohort.PART 2: A total of 16 healthy subjects (8 males and 8 females) will receive single oral doses of XEN-D0103 in 2 treatment periods. The order of the treatment periods for each subject will be determined by chance. Apart from whether subjects will receive a high fat breakfast, both treatment periods will be the same.PART 3: Up to 4 groups of 10 healthy male volunteers may be enrolled. In each group 8 volunteers will receive oral doses of XEN-D0103 and 2 will receive placebo (a dummy treatment). The treatments will be randomly allocated to the volunteers.Subjects will be expected to attend a screening visit, treatment period and follow up visit on each Part of the study.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0077

• Date of REC Opinion

  21 Jun 2011

• REC opinion

  Further Information Favourable Opinion