This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (200 milligrams \[mg\], 600 mg, 1200 mg, 2400 mg) and dose-matched placebo were administered under fasted and fed conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
44
Clinical Trial Site
Auckland, New Zealand
Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), AEs Leading To Discontinuation, And Clinically Significant Laboratory Abnormalities And Electrocardiogram Abnormalities
Time frame: Day 1 through Day 28
Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of Danicopan Under Both Fed And Fasted Conditions
Time frame: Up to 144 hours postdose
Maximal Plasma Concentration (Cmax) Of Danicopan Under Both Fed And Fasted Conditions
Time frame: Up to 144 hours postdose
Time To Reach The Maximal Plasma Concentration (Tmax) Of Danicopan Under Both Fed And Fasted Conditions
Time frame: Up to 144 hours postdose
Relationship Between Alternative Pathway Inhibition And Danicopan Plasma Concentrations
Time frame: Up to 144 hours postdose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.