BIA 5-1058 4 period crossover in Healthy volunteers
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled and open label active-controlled, 4-period crossover trial to evaluate the effect of BIA 5-1058 on cardiac repolarization in healthy adult men and women.
IRAS ID
227578
Contact name
Sunu Valasseri
Contact email
Sponsor organisation
BIAL - Portela & Cª., S.A
Eudract number
2017-001682-25
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
The Study Drug (BIA 5-1058) is an experimental drug being developed by the sponsor as a potential treatment for cardiovascular disease (e.g. pulmonary artery hypertension and heart failure). It works by reducing the activity of the sympathetic nervous system (activates the ‘fight and flight’ response in the body) without affecting the brain. The Study Drug could therefore be used to treat cardiovascular diseases with fewer side effects than the currently available treatments.
The aim of this study is to investigate whether the Study Drug has any effect on the QT interval, an electrical pathway in the heart that can lead to rhythm problems, if conduction in this pathway is prolonged. This will be a 4 period, crossover study in up to 50 healthy male and female subjects under fed conditions. All subjects will receive each of the following 4 treatments; 400mg BIA 5 1058, 1200mg BIA 5 1058, placebo and 400mg moxifloxacin. Moxifloxacin (a marketed antibiotic) is the active control for comparison in this study as this is known to affect the QT interval. The study will be open label for Moxifloxacin but blinded for the study drug and placebo.
Single doses of up to 1200mg of the Study Drug, have been administered in previous studies and were considered safe and well tolerated.
Subjects will be confined to the clinical research unit (CRU) from Day -2 until Day 4, and will receive a single dose of study medication on Day 1, of each treatment period. There will be a washout period of at least 10 days between doses, with a follow up visit around 14 days after discharge from treatment period 4. The total duration of trial participation for each subject (from screening through to the follow up visit) is anticipated to be approximately 80 days.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0025
Date of REC Opinion
27 Feb 2018
REC opinion
Favourable Opinion