This will be an open-label, 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover, food-effect study in healthy young adult participants. Part 2 will be a 1-period age-effect study in healthy elderly male participants.
This will be an open-label, 2-part study. Part 1 will be a randomized, 2-sequence, 2-period crossover, food-effect study in healthy young adult participants. Part 2 will be a 1-period age-effect study in healthy elderly male participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
27
A single dose of danicopan (200 milligrams) will be administered orally.
Clinical Trial Site
Tempe, Arizona, United States
Area Under The Concentration Versus Time Curve From Time 0 To The Last Measurable Concentration (AUC0-t) Of Danicopan Under Both Fed And Fasted Conditions In Healthy Young Adults
Time frame: Up to 72 hours postdose
Area Under The Concentration Versus Time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) Of Danicopan Under Both Fed And Fasted Conditions In Healthy Young Adults
Time frame: Up to 72 hours postdose
Maximum Observed Concentration (Cmax) Of Danicopan Under Both Fed And Fasted Conditions in Healthy Young Adults
Time frame: Up to 72 hours postdose
Time To Maximum Observed Concentration (Tmax) Of Danicopan Under Both Fed And Fasted Conditions in Healthy Young Adults
Time frame: Up to 72 hours postdose
AUC0-t Of Danicopan Under Fed Conditions In Healthy Elderly Males
Time frame: Up to 72 hours postdose
AUC0-inf Of Danicopan Under Fed Conditions In Healthy Elderly Males
Time frame: Up to 72 hours postdose
Cmax Of Danicopan Under Fed Conditions In Healthy Elderly Males
Time frame: Up to 72 hours postdose
Tmax Of Danicopan Under Fed Conditions In Healthy Elderly Males
Time frame: Up to 72 hours postdose
Number Of Healthy Young Adults And Healthy Elderly Males With Treatment-emergent Adverse Events
Time frame: Day 1 (postdose) through follow-up (10 [+/- 2] days after last study drug administration)
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