Mass Balance Study of [14C]-Paxalisib In Healthy Males (QSC204878)
Research type
Research Study
Full title
An Open-Label, Single-Dose, Single-Period Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Paxalisib in Healthy Male Subjects
IRAS ID
295213
Contact name
James Garner
Contact email
Sponsor organisation
Kazia Therapeutics Limited
Eudract number
2021-001517-36
Duration of Study in the UK
0 years, 1 months, 8 days
Research summary
The Sponsor is developing the test medicine, Paxalisib, for the potential treatment of certain types of brain cancer, such as gliomas (tumours that occur in the brain and spinal cord). The test medicine has been shown to reduce the growth of gliomas in non-human studies.
The study involves radiolabelling (labelling the test medicine with radioactive 14C) which is used to locate the test medicine within the body. The study will try to assess how much radioactivity can be recovered from the urine and faeces (mass balance) and the routes of elimination. It will also try to determine what the body does to the test medicine (pharmacokinetics). It will try to identify which metabolites (breakdown products) are generated. Safety and tolerability will also be assessed.
This is a single period study involving up to six healthy male volunteers. Volunteers will receive a single oral dose of 15 mg [14C]-Paxalisib as a capsule. Volunteers will remain in the clinical unit for at least 168 hours post-dose (Day 8). Blood, urine and faeces samples will be collected whilst volunteers are resident in the unit. If discharge criteria are not met by Day 8, then additional residency up to Day 10 or home collections of urine and/or faeces may be required. A follow-up phone call will take place five to seven days after the final collection period, to ensure the ongoing wellbeing of participants.
REC name
HSC REC A
REC reference
21/NI/0104
Date of REC Opinion
20 Jul 2021
REC opinion
Further Information Favourable Opinion