This is an interventional, first-in-man study, double-blind, placebo-controlled, two-part, ascending doses study to investigate the safety, tolerability and efficacy of STR-324 infusions in healthy volunteers.
Part I : ascending doses of short lasting infusion Part II : ascending doses of long lasting infusion
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
Short infusion of the solution for intravenous administration, Sodium Chloride 0.9%
Short infusion of a solution for intravenous administration
Short infusion of a solution for intravenous administration
CHDR
Leiden, Netherlands
Safety and tolerability: number of subjects who experience (serious) treatment emergent adverse events, potential clinically changes in vital signs, ECG, holter, physical examinations, laboratory tests and urine production
Time frame: Day 7 (+/- 2 days) post dosing
Parts I and II: Maximum plasma concentration (Cmax)
Time frame: Up to 24 hours for Part I and up to 52 hours for Part II
Parts I and II:Time to maximum plasma concentration (Tmax)
Time frame: Up to 24 hours for Part I and up to 52 hours for Part II
Parts I and II: Area under the plasma concentration-time curve from zero to infinity(AUC0-inf)
Time frame: Up to 24 hours for Part I and up to 52 hours for Part II
Parts I and II: Area under the plasma concentration-time curve from zero to the last measured concentration above the limit of quantification (AUC0-last)
Time frame: Up to 24 hours for Part I and up to 52 hours for Part II
Parts I and II: Terminal disposition rate constant (λz) with the respective half-life (t½)
Time frame: Up to 24 hours for Part I and up to 52 hours for Part II
Parts I and II: Amount excreted in urine in 24 hours
Time frame: Up to 24 hours for Part I and up to 72 hours for Part II
Parts I and II: Thermal Pain
Time frame: Up to 5 hours for part I and up to 56 hours for part II
Parts I and II: Electrical pain Stair and Burst
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Short infusion of a solution for intravenous administration
Short infusion of a solution for intravenous administration
Short infusion of a solution for intravenous administration
Short infusion of a solution for intravenous administration
Short infusion of a solution for intravenous administration
Short infusion of a solution for intravenous administration
Long infusion of a solution for intravenous administration
Long infusion of a solution for intravenous administration
Long infusion of a solution for intravenous administration
Long infusion of the solution for intravenous administration, Sodium Chloride 0.9%
Time frame: Up to 5 hours for part I and up to 56 hours for part II
Parts I and II: Pressure Pain
Time frame: Up to 5 hours for part I and up to 56 hours for part II
Parts I and II: Cold Pressor
Time frame: Up to 5 hours for part I and up to 56 hours for part II
Parts I and II: Conditioned Pain Modulation Response (change from electrical stair pre- and post-cold pressor)
Time frame: Up to 5 hours for part I and up to 56 hours for part II
Parts I and II: Visual Analogue Scale Bond & Lader
Time frame: Up to 5 hours for part I and up to 56 hours for part II
Parts I and II: Visual Analogue Scale Bowdle
Time frame: Up to 5 hours for part I and up to 56 hours for part II
Part II only: Saccadic eye movement
Time frame: Up to 56 hours
Part II only: Smooth pursuit eye movement
Time frame: Up to 56 hours
Part II only: Adaptive tracking
Time frame: Up to 56 hours
Part II only: Body sway
Time frame: Up to 56 hours
Part II only: N-Back
Time frame: Up to 56 hours
Part II only: Pharmaco-EEG: power
Time frame: Up to 56 hours
Part II only: Pupillometry
Time frame: Up to 56 hours
Part II only: 49-item Addiction Center Research Inventory
Time frame: Up to 60 hours
Part II only: Bowel Function Index
Time frame: Up to day 7
Part II - Groups 2 and 3 only: Thermal pain (Normal skin and erythema skin - UVB)
Time frame: Up to 24 hours