ADME of [14C]-Varlitinib in Healthy Male Subjects (QCL117909)
Research type
Research Study
Full title
An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Varlitinib in Healthy Male Subjects
IRAS ID
229494
Contact name
Jenny Chen
Contact email
Sponsor organisation
Aslan Pharmaceuticals
Eudract number
2017-000886-57
Clinicaltrials.gov Identifier
NCT03368846,
Duration of Study in the UK
0 years, 1 months, 2 days
Research summary
The Sponsor is developing the test medicine, varlitinib, for the potential treatment of several different cancers. The test medicine inhibits (blocks) specific signalling pathways in the body. It has been shown in other medicines that blocking these pathways is an effective treatment in some cancers. However there is still a need to develop a better medicine to more effectively block these pathways.
The study will use radiolabelled varlitinib to identify how the medicine is taken up, absorbed, processed and removed by the body. Radiolabelled means that the test medicine has a radioactive component which helps us to track where the drug is in the body. The type of radioactivity used, carbon-14, is naturally occurring radioactivity that will allow us to trace the study drug in the blood and assess how much is being taken up into / broken down in the body.
The safety and tolerability of the test medicine will also be assessed.
It is planned to dose a single group of 6 healthy male volunteers. Each volunteer will receive a single oral radiolabelled dose of 120 mg varlitinib, in the fed state.
REC name
HSC REC B
REC reference
17/NI/0166
Date of REC Opinion
21 Sep 2017
REC opinion
Further Information Favourable Opinion