Effects of XEN-D0103 on warfarin, midazolam, digoxin pharmocokinetics
Research type
Research Study
Full title
A Phase 1 open label study to assess the effects of XEN-D0103 on the pharmacokinetics of warfarin, midazolam and digoxin in healthy male subjects
IRAS ID
100113
Contact name
Darren Wilbraham
Sponsor organisation
Xention Limited
Eudract number
2011-005552-34
Research summary
The drug being tested in this study, XEN-D0103, is being developed for the possible treatment of a type of heart rhythm disorder that results in a fast/irregular heartbeat called atrial fibrillation. This will be the second time this drug will be given to human volunteers. Before investigating XEN-D0103 in patient studies it is important to see whether it affects the way other prescription drugs may be broken down in the body. The purpose of this study is to examine the safety, tolerability and the way the body handles (absorbs, distributes, breaks down and excretes) multiple oral doses of XEN-D0103 in combination with single doses of warfarin, midazolam and digoxin in healthy male volunteers and elucidate any potential drug-drug interactions that may affect future patient studies. The study will take place at Quintiles Drug Research Unit at Guy??s Hospital, Quintiles Ltd. The study will involve one group of 16 healthy male volunteers. There will be 2 periods for this study. Volunteers will receive a single dose of warfarin, midazolam and digoxin during the first period. Following safety assessment, the same group of volunteers will be readmitted for period 2, whereby they will be administered twice-daily dose of Xen-D0103 for 10 days. In addition, a single dose of warfarin, midazolam and digoxin will also be given. There will be four visits to the unit - screening, 2 residential periods, 1 outpatient follow up. The length of time from the first admission to end of study is 28 days.
REC name
London - London Bridge Research Ethics Committee
REC reference
12/LO/0274
Date of REC Opinion
8 Mar 2012
REC opinion
Favourable Opinion