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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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