Safety, tolerability,PK, transcranial magnetic stimulation of XEN1101
Research type
Research Study
Full title
A Double-blind, Placebo-controlled Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effects on Transcranial Magnetic Stimulation of Oral Administration of XEN1101 in Healthy Male Subjects
IRAS ID
233315
Contact name
Mark Richardson
Contact email
Sponsor organisation
Xenon Pharmaceuticals Inc.
Eudract number
2017-003181-27
Duration of Study in the UK
0 years, 5 months, 29 days
Research summary
This is a companion trial to the first in human (FIH) trial (Protocol # XPF-008-101a, REC Reference 17/SC/0413) of XPF-008, the powder in capsule formulation of XEN1101, an investigational drug under development for the treatment of epilepsy (focal seizures).
This trial will investigate safety, tolerability and how well absorbed and how long XEN1101 stays in blood (Pharmacokinetics) and will evaluate the potential effects on cortical excitability (Pharmacodynamics) using Transcranial Magnetic stimulation (TMS) in healthy right-handed male volunteers aged 18 – 55 years.
An estimated 15 volunteers (maximum 20) will be enrolled into the trial.
This is a cross-over trial whereby volunteers will complete two treatment periods, followed by a follow up period. Volunteers will be randomised in a blinded fashion to receive either a single oral dose of XPF-008 or placebo (1:1 randomization ratio) in the first treatment period, followed by the opposite treatment in the second treatment period.
The dose used in this trial will be a well-tolerated and pharmacologically active dose, and will be decided by a Safety Review Committee (SRC) based on emerging data from the preceding XPF-008-101a trial.
Up to 20 volunteers will be admitted to the TMS unit and dosed on Day 1, and discharged on Day 2. All volunteers will be readmitted to the unit and dosed on Day 7, and discharged on Day 8. All volunteers will attend an outpatient visit on Day 14 and receive a follow-up phone-call on Day 37.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0542
Date of REC Opinion
19 Dec 2017
REC opinion
Further Information Favourable Opinion