* A Mass Balance Study of [14C]-BPN14770 Oral Capsule In Healthy Adult Male Participants (QSC206367)
Research type
Research Study
Full title
A Single-group, Phase 1, Open-label Study to Investigate the Absorption, Distribution, Metabolism and Excretion of [14C]-BPN14770 Following Oral Dose Administration as a Capsule in Healthy Adult Male Participants.
IRAS ID
1005653
Contact name
Mia Hughes
Contact email
Sponsor organisation
Shionogi B.V.
Eudract number
2022-000395-19
ISRCTN Number
ISRCTN14188712
Research summary
The Sponsor is developing a new test medicine for the potential treatment of cognitive disorders (diseases which affect how the brain works), such as fragile X syndrome, a genetic disorder which may cause learning disabilities and cognitive impairment; and Alzheimer’s Disease, which causes the brain to shrink and die and is characterised by cognitive decline (for example, confusion or memory loss).\n\nThis single-part, healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. To help investigate this, the test medicine is radiolabelled, which means that the test medicine has a radioactive component (carbon-14) which helps us to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be studied.\nThis study will take place at one non-NHS site, and will consist of a single study period involving up to 6 male volunteers, aged between 30 to 65 years.\nOn Day 1, volunteers will receive a single oral dose of the radiolabelled test medicine in the fasted state (on an empty stomach).\nVolunteer’s blood, urine and faeces will be taken throughout the study for analysis of the test medicine and its breakdown products (metabolites) and for volunteer safety. \nVolunteers will remain in the clinical unit until Day 8, however if the relevant radioactivity criteria have not been met, volunteers may be required to remain at the clinic until Day 15. If relevant criteria have not been met at this point, home collections of urine and/or faeces may be required. \nVolunteers are expected to be involved in this study for approximately 6 weeks from screening to discharge.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/FT/0079
Date of REC Opinion
21 Jul 2022
REC opinion
Further Information Favourable Opinion