* Mass Balance Study of [14C]-NV-5138 in Healthy Males (QSC203295)
Research type
Research Study
Full title
An open-label, single dose, mass balance study to assess the disposition of [14C]-NV-5138 in healthy male subjects
IRAS ID
304624
Contact name
J. Randall Owen, MD
Contact email
Sponsor organisation
Navitor Pharmacueticals
Eudract number
2021-004403-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 1 days
Research summary
The Sponsor is developing the test medicine, NV-5138, for the potential treatment of treatment resistant depression, a condition that affects people with major depressive disorder (MDD), a common psychiatric disorder. Although there are a number of treatments for MDD, it is common for patients to take 6 to 12 weeks to respond to treatment. The test medicine is being developed to provide a rapid onset antidepressant response, whereas the standard antidepressant treatments usually take a longer time to provide an antidepressant response.
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 try to identify which metabolites (breakdown products) are generated. It will also try to determine what the body does to the test medicine (pharmacokinetics). Safety and tolerability will also be assessed.
The study will consist of a single period involving six healthy male volunteers. Volunteers will receive a single dose of [14C]-NV-5138 as an oral solution. Volunteers are expected to remain in the clinical unit until 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.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
21/FT/0152
Date of REC Opinion
29 Oct 2021
REC opinion
Further Information Favourable Opinion