This is a Phase 0, open-label, non-controlled, single-centre study designed to evaluate the pharmacokinetics (PK) and safety and tolerability of a single, bolus intravenous (iv) injection of a microdose of ACD856 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
IV injection 100 mcg
Uppsala University Hospital
Uppsala, Sweden
Area under the plasma concentration vs time curve from time zero extrapolated to infinity
a pharmacokinetic measure of the amount of study medication present in the blood
Time frame: 24 hours
AUC from time zero to time of last quantifiable analyte concentration
a pharmacokinetic measure of the amount of study medication present in the blood
Time frame: 96 hours
Half-life associated with terminal slope of a semi-logarithmic concentration-time curve
a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood
Time frame: 24 hours
Total body clearance following iv administration
a pharmacokinetic measure of the time it takes for the study drug to be eliminated from the blood
Time frame: 24 hours
Volume of distribution following iv administration
a theoretical estimate of how much of the study drug that the body may contain
Time frame: 24 hours
Number of subjects with adverse events
how many participants have reported a drug related advers event
Time frame: 5 days
Number of subjects with clinically significant changes in vital signs
how many participants have had any clinically significant changes in vital signs
Time frame: 5 days
Number of subjects with clinically significant changes in 12-lead electrocardiograms (ECGs)
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how many participants have had study drug related changes to cardiac function
Time frame: 5 days
Number of subjects with clinically significant changes in haematology and clinical chemistry and/or urinalysis
how many participants have had study drug related changes in laboratory test analyses
Time frame: 5 days