This is a Phase l double-blind, placebo-controlled, randomized study to investigate the safety, tolerability, pharmacokinetics, bioavailability and food effect of single doses of APX001 administered intravenously and orally, followed by an evaluation of the safety, tolerability, pharmacokinetics and drug-drug interaction potential of multiple doses of APX001 administered orally.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
PRA Health Sciences (PRA) - Early Development Services (EDS)
Groningen, Netherlands
PRA Health Sciences
Groningen, Netherlands
Safety and tolerability of single and multiple oral doses of APX001 as measured by adverse events (AEs), physical examinations (PE), vital signs (VS), laboratory safety tests, urinalysis and 12-lead electrocardiograms (ECG).
Time frame: 21 days
Pharmacokinetics of single and multiple doses of APX001 as measured by maximum observed concentration (Cmax).
Time frame: 21 days
Pharmacokinetics of single and multiple dose of APX001 as measured by area under the curve (AUC).
Time frame: 21 days
Pharmacokinetics of single and multiple doses of APX001 as measured by terminal half life (t1/2).
Time frame: 21 days
Pharmacokinetics of single and multiple doses of APX001 as measured by volume of distribution (Vd).
Time frame: 21 days
Pharmacokinetics of single and multiple doses of APX001 as measured by elimination rate constant (Kel).
Time frame: 21 days
Pharmacokinetics of single and multiple doses of APX001 as measured by accumulation ratio.
Time frame: 21 days
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