Single center, randomized, open label, two-part crossover study designed to evaluate the PK, food effect, dose proportionality, safety, and tolerability of BLD-2660 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Randomized to active product
Scientia Clinical Research
Randwick, New South Wales, Australia
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)
Measured by plasma concentration
Time frame: Up to 40 days
AUC from time 0 to infinity (AUC0-inf)
Measured by plasma concentration
Time frame: Up to 40 days
Maximum observed drug concentration (Cmax)
Measured by plasma concentration
Time frame: Up to 40 days
Time of the maximum drug concentration (Tmax)
Measured by plasma concentration
Time frame: Up to 40 days
Apparent terminal half-life (t½)
Measured by plasma concentration
Time frame: Up to 40 days
Apparent terminal elimination rate constant (Kel)
Measured by plasma concentration
Time frame: Up to 40 days
Incidence of adverse events (AEs)
AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
Time frame: Up to 40 days
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