(QSC118239) ADME Study of Oral [14C]-BIA 5-1058 in Healthy Males
Research type
Research Study
Full title
An Open-Label Study to Assess the Absorption, Distribution, Metabolism and Excretion, including the Mass Balance Recovery, Metabolite Profiling and Identification, of [14C]-Labelled BIA 5-1058 Following a Single Oral Dose Administration in Healthy Male Subjects
IRAS ID
254334
Contact name
João Ferreira
Contact email
Sponsor organisation
BIAL - Portela & Ca, S.A
Eudract number
2018-003995-11
Duration of Study in the UK
0 years, 2 months, 24 days
Research summary
The sponsor is developing the test medicine, BIA 5-1058, for the treatment of cardiovascular diseases. Cardiovascular disease is a general term that describes conditions affecting the heart or blood vessels. These conditions can lead to damage to arteries in organs such as the brain, heart and kidneys. Examples of cardiovascular disease include coronary heart disease (a reduction in oxygen rich blood reaching the heart muscle) and strokes.
The study will try to identify how BIA 5-1058 is absorbed (taken up), distributed, metabolised (broken down) and eliminated (removed) from the body. The safety and tolerability of the study drug will also be investigated.
The study is an open-label, single dose study involving 8 healthy male volunteers. The volunteers will receive a single dose of 400 mg radiolabelled BIA 5-1058 ([14C]-BIA 5-1058) containing not more than 4.6 MBq of radioactivity, in the form of a capsule by mouth. ‘Radiolabelled’ means that the study drug has a radioactive component which enables researchers to track where the test medicine is in the body.
Volunteers will attend the clinic for 16 days (Day -1 to Day 15) to receive a single dose of the study drug. It is planned that the volunteers will be discharged as a group once the discharge criteria have been met. This may result in the subjects being discharged as a group prior to completion of the planned residency period. If the criteria are not met by the individual volunteer by Day 15, they will return to the clinic for up to five further 24-hour residency periods on Days 21-22, 28-29, 42-43, 56-57 and 77-78 until the criteria are met. It is foreseen that all subjects will be discharged from the study no later than Day 78.
REC name
HSC REC A
REC reference
18/NI/0217
Date of REC Opinion
3 Dec 2018
REC opinion
Favourable Opinion