This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of danicopan after a single-dose oral administration under fed and fasting conditions to participants of Japanese descent.
This will be an open-label, randomized, single-dose, 3-period, 3-treatment crossover study in participants of Japanese descent. On Day 1 of each period, participants will receive a single oral dose of 200 milligrams (mg) danicopan under fasting conditions, 200 mg danicopan under fed conditions, or 400 mg danicopan under fed conditions. Participants will receive each treatment once, according to the randomization schedule. There will be a washout period of at least 7 days between each dose of study intervention. Safety will be assessed throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Oral tablet
Clinical Study Site
Brisbane, Australia
Number Of Participants With Treatment-Emergent Adverse Events
Time frame: Day 1 (after first dose) through safety follow-up (10 +/- 2 days after last dose)
Area Under The Concentration Versus Time Curve (AUC) Of Danicopan In Both Fed And Fasted States
Time frame: up to 72 hours postdose
Maximum Observed Concentration (Cmax) Of Danicopan In Both Fed And Fasted States
Time frame: up to 72 hours postdose
Time To Maximum Observed Concentration (Tmax) Of Danicopan In Both Fed And Fasted States
Time frame: up to 72 hours postdose
Dose Proportionality Of Danicopan In Fed State Assessed by AUC
Time frame: up to 72 hours postdose
Dose Proportionality Of Danicopan In Fed State Assessed by Cmax
Time frame: up to 72 hours postdose
Activity Of Danicopan As Measured By Alternative Pathway Wieslab Assay
Blood samples will be collected for measurement of danicopan activity.
Time frame: up to 72 hours postdose
Complement Factor B Fraction b Levels
Blood samples will be collected for measurement of complement factor B fraction b levels.
Time frame: up to 72 hours postdose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.