Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 5-1058
Status:
Completed
Trial end date:
2019-03-18
Target enrollment:
Participant gender:
Summary
This is a single centre, double-blind, randomised, placebo-controlled, parallel staggered
group study of BIA 5-1058 in 11 different cohorts of 15 healthy subjects. Subjects will be
randomly assigned to receive once-daily oral doses of BIA 5-1058 or matching placebo for 10
days.
The primary objectives of the study are to assess the safety and tolerability of BIA 5-1058
after repeated ascending doses under fed and fasted conditions and to assess the
pharmacokinetics (PK) of BIA 5-1058 after repeated ascending doses under fed conditions
having matching fasting cohorts for comparison of bioavailability.
It is planned that comparison cohorts will be dosed in parallel, i.e. Cohorts 1 and 2, 3 and
4, 5 and 6, 7 and 8 and 9 and 10. Cohorts may be split or dosed sequentially for logistical
purposes; however, data from both comparison cohorts (e.g. Cohorts 1 and 2) must be available
before dose escalation to the next dose levels.