This was a multiple ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (75 milligrams \[mg\], 200 mg, 500 mg, 800 mg) and dose-matched placebo were administered under fasted conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
45
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 42
Maximum Observed Plasma Concentration (Cmax) Of Danicopan
Time frame: Up to 16 hours postdose
Time To Maximum Observed Plasma Concentration (Tmax) Of Danicopan
Time frame: Up to 16 hours postdose
Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Danicopan
Time frame: Up to 16 hours postdose
Activity Of Danicopan As Measured By Alternative Pathway (AP) Wieslab Assay
Time frame: Up to 16 hours postdose
Relationship Between AP Inhibition And Danicopan Plasma Concentrations
Time frame: Up to 16 hours postdose
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