Phase 1 ADME study of [14C]-NW-3509 in healthy males (QCL118158)
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]-NW-3509 in Healthy Male Subjects
IRAS ID
239835
Contact name
Ravi Anand
Contact email
Sponsor organisation
Newron Pharmaceuticals SpA
Eudract number
2017-004336-11
Duration of Study in the UK
0 years, 3 months, 30 days
Research summary
The Sponsor is developing the study drug, NW-3509, for the potential treatment of schizophrenia, mania and bipolar disorders. Schizophrenia is a severe long-term mental health condition. It causes a range of different psychological symptoms such as hallucinations, delusions and muddled thoughts. Bipolar disorder, formerly known as manic depression, is a condition that affects your moods, which can swing from one extreme to another. NW-3509 works by reducing the over activity in parts of the brain which is associated with schizophrenia and is hoped to be a new treatment option for schizophrenia, mania and bipolar disorders.
The study will try to identify how the study drug is absorbed, distributed, broken down and removed from the body. The study drug will be radiolabelled to be analysed as it moves through the body ([14C]-NW-3509). The safety and tolerability of the study drug will also be investigated.
The study is an open-label, single dose study in up to 6 healthy male volunteers. Volunteers will attend the clinical unit on one occasion to receive one dose of 25 mg [14C]-NW-3509 given by mouth. Blood, urine and faeces will be collected at pre-defined time points up to 336 hours after dosing (up to Day 15). It is planned that the volunteers will be discharged as a group once the discharge criteria have been met. If the criterion have not been met by Day 15, home collections of urine and/or faeces may be requested at the discretion of the investigator for individual volunteers.
REC name
HSC REC A
REC reference
18/NI/0029
Date of REC Opinion
7 Mar 2018
REC opinion
Favourable Opinion