Safety, Tolerability and PK of XEN901 in Healthy Subjects (QCL118145)
Research type
Research Study
Full title
Phase 1, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901 in Healthy Subjects
IRAS ID
238097
Contact name
Y. Paul Goldberg
Contact email
Sponsor organisation
Xenon Pharmaceuticals Inc.
Eudract number
2017-004046-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 15 days
Research summary
The sponsor Xenon Pharmaceuticals Inc. is developing a new medicine, XEN901, for the potential treatment of epilepsy.
Epilepsy is a broad term for a neurological disease characterised by the recurrence of seizures. Seizures are bursts of electrical activity in the brain that temporarily affect how it works. They can cause a wide range of symptoms including uncontrollable jerking and shaking which is known as a "fit".
The study will try to identify the safety, tolerability and pharmacokinetics (how well the study drug is taken up by the body) of single and multiple doses of the test medicine given by mouth, in healthy volunteers.
This is the first time the medicine has been dosed in humans.
In Part 1, approximately 40 volunteers will be dosed in 1 of 6 cohorts (groups). Each volunteer will receive a single dose of the test medicine, or placebo (dummy drug), in the fasted state (without food). After dosing volunteers will remain in the clinical unit for 30 hours for blood samples to be taken and safety assessments performed. The starting dose of Part 1 is 5 mg XEN901 and safety, tolerability and pharmacokinetic data (24 hours) will be reviewed after each group is dosed to decide the dose that will be given in the next group.
In Part 2, approximately 24 volunteers will be dosed in 1 of 3 groups. Each volunteer will receive multiple doses of the test medicine, or placebo, as a single dose three times a day for 7 consecutive days. Volunteers will remain in the clinical unit for 30 hours after their last dose for blood samples to be taken and safety assessments performed. Part 2 will only proceed once the last group has been dosed in Part 1. The starting dose of Part 2 will be decided on safety, tolerability and pharmacokinetic data from Part 1.
REC name
HSC REC B
REC reference
18/NI/0008
Date of REC Opinion
23 Jan 2018
REC opinion
Further Information Favourable Opinion