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.
Age range
18 Years – 55 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Cmax: maximum observed concentration
Timeframe: Day 1, Day 6 and Day 10
Cmin: minimum observed concentration at steady state
Timeframe: Day 1, Day 6 and Day 10
Tlag: the elapsed time from dosing at which analyte was first quantifiable in a concentration vs time profile
Timeframe: Day 1, Day 6 and Day 10
Tmax: the time from dosing at which Cmax was apparent
Timeframe: Day 1, Day 6 and Day 10
AUC(0-t): area under the curve from 0 time to last measurable concentration
Timeframe: Day 1, Day 6 and Day 10
AUC(0-tau): area under the curve during a dosing interval
Timeframe: Day 1, Day 6 and Day 10
AUC(0-inf): area under the curve from 0 time extrapolated to infinity
Timeframe: Day 1, Day 6 and Day 10
AUC%extrap: percentage of AUC(0-inf) extrapolated beyond last measured time point
Timeframe: Day 1, Day 6 and Day 10
Lambda-z: the slope of the apparent elimination phase
Timeframe: Day 1, Day 6 and Day 10
t1/2: the apparent elimination half-life
Timeframe: Day 1, Day 6 and Day 10
Cl/F: clearance, the apparent volume cleared of parent drug per unit time after extravascular administration
Timeframe: Day 1, Day 6 and Day 10
MRT: mean residence time
Timeframe: Day 1, Day 6 and Day 10