Mass Balance Recovery and Metabolite Identification of 14C-BIA 28-6156
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-BIA 28-6156 in Healthy Male Subjects
IRAS ID
300652
Contact name
Nuno Mendonça
Contact email
Sponsor organisation
BIAL R&D Investments S.A.
Eudract number
2021-003018-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 6 days
Research summary
Summary of Research
The Sponsor is developing the test medicine, BIA 28-6156, for the potential treatment of a type of Parkinson’s disease, called GBA associated Parkinson’s disease (GBA-PD).Parkinson's disease is a condition in which parts of the brain become increasingly damaged over many years and is caused by the loss of nerve cells in part of the brain. It is one of the most common degenerative disorders with very poor outcomes. There is currently no cure and standard therapies treat the symptoms and not the disease itself, so new treatments are needed.
This study will aim to look at how the test medicine is taken up, broken down and removed by the body when given as an oral capsule. To help investigate how this happens, 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.
The study will consist of a single study period involving up to 6 healthy male volunteers, aged 30 - 65. Volunteers will be admitted to the clinic the evening before the day of dosing. On Day 1, following an overnight fast of at least 8 hours, volunteers will receive a single 60 mg dose of the radiolabelled test medicine as a capsule to be swallowed.
Blood, urine and faecal samples will be collected throughout the study. Volunteers will remain in the clinic up to Day 13, however if the relevant radioactivity criteria have been met for all volunteers in the study before Day 13, the volunteers may be discharged early as a group. If the relevant radioactivity criteria have not been met by Day 13, home collections of urine and/or faeces may be required.
Summary of Results
Given that this is a Phase I trial, no lay summary of results has been provided for reasons of commercial confidentiality.REC name
Wales REC 2
REC reference
21/WA/0245
Date of REC Opinion
13 Aug 2021
REC opinion
Favourable Opinion