ADME study of [14C]-BIA 9-1067 in healthy male subjects (QCL117756)
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 9-1067 in Healthy Male Subjects
IRAS ID
217460
Contact name
Jose Francisco Rocha
Contact email
Sponsor organisation
BIAL - Portela & Cª., S.A.
Eudract number
2016-004454-15
Duration of Study in the UK
0 years, 3 months, 2 days
Research summary
The Sponsor has developed BIA 9-1067 for the treatment of Parkinson’s Disease. Parkinson’s Disease is a disease of the brain and causes shaking of the body (tremor), slow movement and stiff muscles.
The study will be carried out in seven healthy male subjects to measure how BIA 9-1067 is taken up, broken down and removed by the body. The break down products of BIA 9-1067 will also be identified.
Seven male subjects will receive a single dose of 100 mg of radiolabelled BIA 9-1067 ([14C]-BIA 9-1067) as a capsule by mouth. ‘Radiolabelled’ means that the study drug has a radioactive component which enables researchers to track where the study drug is in the body. Subjects will remain resident in the clinical unit for 23 days (Day -1 to Day 22). Blood, urine, faecal and expired air samples will be collected at regular intervals during this clinical stay.
Six days after discharge from the clinical unit (Day 28), subjects will return for either a short visit or overnight stay. This will depend on whether the discharge criteria were met when subjects were discharged on Day 22. If subjects are required to stay overnight, blood, urine and faecal samples will be collected. If they return to the clinical unit for a short visit they will only be required to provide a blood sample. All subjects will attend the clinical unit for up to three further visits to provide a blood sample (Day 42, Day 56 and Day 77 all ±3 days).
REC name
HSC REC B
REC reference
17/NI/0003
Date of REC Opinion
18 Jan 2017
REC opinion
Further Information Favourable Opinion