Phase 1 PK and PD study of BIA 5-1058 in healthy subjects (QCL118167)
Research type
Research Study
Full title
A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses Of BIA 5-1058 in Healthy Volunteers
IRAS ID
232148
Contact name
Nand Singh
Contact email
Sponsor organisation
BIAL – Portela & Ca, S.A.
Eudract number
2018-000113-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 2 days
Research summary
The Sponsor is developing the study drug, BIA 5-1058, for the potential treatment of cardiovascular diseases, which are a collection of diseases which affect the heart or blood vessels, such as high blood pressure (hypertension).
The study will try to identify the safety and tolerability of BIA 5-1058 after repeated increasing doses. It will also look at how the test medicine is taken up by the body and whether food has an effect on how the test medicine is taken up by the body.
The study will consist of 1 part involving up to 150 healthy male and female subjects in 10 cohorts (groups). The subjects will be randomly assigned to receive either BIA 5-1058 or matching placebo (dummy test medicine) once-daily for 10 days in either the fasted or fed state. Each cohort will follow the same study design, subjects will receive a once daily dose from Day 1 until Day 10 and will remain in clinic until 72 hours post their last dose (Day 13). After each cohort has been completed, an interim review of safety and the level of BIA 5-1058 in the blood will be performed to confirm the dosing regimen that the next cohort will receive. Subjects will return to the clinic for a follow up visit between 12 to 16 days after their final dose to check on their continued wellbeing.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/0380
Date of REC Opinion
26 Mar 2018
REC opinion
Further Information Favourable Opinion