Mass balance study of [14C]-SPN-817 in healthy male subjects (QSC205262)
Research type
Research Study
Full title
An open-label, single period, multiple dose study designed to assess the mass balance, metabolite profile and metabolite identification of [14C]-SPN-817 in healthy male subjects
IRAS ID
1004367
Contact name
Jonathan Rubin
Contact email
Sponsor organisation
Supernus Pharmaceuticals, Inc.
Eudract number
2021-004066-35
ISRCTN Number
ISRCTN21667877
Research summary
The Sponsor is developing the test medicine, SPN-817, for the treatment of neurological disorders such as epilepsy. Epilepsy is usually a lifelong disorder that affects the brain and can cause loss of awareness and seizures.
This healthy volunteer study will try to assess how the body tolerates increasing doses of the test medicine and how it is taken up, broken down and removed by the body. To help investigate this, the final dose of the test medicine will be radiolabelled. ‘Radiolabelled’ means that the test medicine has a radioactive component (Carbon-14) which enables the test medicine to be tracked in the body. The safety and tolerability of the test medicine will also be studied.
This study will take place at one non-NHS site and will consist of a single study period involving 8 healthy male volunteers aged 30 to 64.
On Days 1 to 20, volunteers will receive doses of the non-radiolabelled test medicine in the form of oral capsule(s), in the morning and evening. To assess how the body tolerates increasing doses of the test medicine, the doses will be increased daily.
On Days 21 and 22, volunteers will receive a single dose of the test medicine in the form of an oral liquid. On Day 22, the test medicine will be radiolabelled.
Volunteers will be dosed on an empty stomach on each occasion. Blood, urine and faecal samples will be collected throughout the study.
Volunteers will remain in the clinic up to Day 29, however if the relevant radioactivity criteria have not been met, volunteers may be required to remain at the clinic until Day 31. If relevant criteria have not been met at this point, home collections of urine and/or faeces may be required.
Volunteers are expected to be involved in this study for approximately 8 weeks.
REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0377
Date of REC Opinion
27 Jun 2022
REC opinion
Further Information Favourable Opinion