* Mass Balance & Metabolite Study of 14C-XEN1101 (QSC204463)
Research type
Research Study
Full title
An Open Label, Single-dose, Single-period Study to Assess the Pharmacokinetics, Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-XEN1101 in Healthy Male Subjects
IRAS ID
295531
Contact name
Nand Singh
Contact email
Sponsor organisation
Xenon Pharmaceuticals Inc.
Eudract number
2021-000735-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 19 days
Research summary
Research Summary:
The Sponsor is developing the test medicine, XEN1101, for the potential treatment of epilepsy.This is not the first time this medicine (XEN1101) has been given to people. More than 100 healthy volunteers and epilepsy patients have taken XEN1101 on one or more occasions in Phase I studies.
The purpose of this study is to look at the way XEN1101 is taken up, broken down, and removed from the body when given as an oral capsule (by mouth). We will also look at the safety and tolerability of the test medicine.
The study will consist of 7 study visits(including the screening visit) involving up to 6 healthy male volunteers. Volunteers will attend the unit for 1 residential period where they will be dosed with the test medicine and remain within the clinical unit for up to 22 days. All volunteers will receive a single 20 mg oral dose of the test medicine, labelled with not more than 4.3 MBq of 14C, on Day 1. The test medicine will be radiolabelled, this means that the test medicine has a radioactive component which helps to track where it is in the body. The type of radioactivity used, carbon 14, is a type of naturally occurring radioactivity that will allow us to trace the test medicine in the blood and assess how much is being taken up into / broken down in the body.
Volunteers will be allowed to leave the clinic once all volunteers have met the discharge criteria. This may result in them being discharged as a group before the full 22 days in-clinic stay is over. Volunteers not achieving the mass balance recovery criteria will also attend up to five 24 hour-return visits at weekly intervals.
Blood, urine and faecal samples will be collected from volunteers whilst they reside in the clinical unit.
Lay summary of study results:
Given that this is a Phase I trial, no lay summary of results has been provided for reasons of commercial confidentiality.REC name
London - London Bridge Research Ethics Committee
REC reference
21/FT/0063
Date of REC Opinion
1 Jun 2021
REC opinion
Favourable Opinion