This was an open-label, nonrandomized, multi-center, single-dose, parallel group study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan (ACH-0144471) compared to demographically-matched healthy participants with normal renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
Oral tablet.
Clinical Trial Site
Miami, Florida, United States
Clinical Trial Site
Orlando, Florida, United States
Clinical Trial Site
Minneapolis, Minnesota, United States
Clinical Trial Site
Saint Paul, Minnesota, United States
Participants With Treatment-emergent Adverse Events
Time frame: Day 1 through Day 10 (+/- 2 days)
Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of Danicopan
Time frame: Up to 72 hours postdose
Maximum Observed Plasma Concentration (Cmax) Of Danicopan
Time frame: Up to 72 hours postdose
Time To Reach The Maximum Observed Plasma Concentration (Tmax) Of Danicopan
Time frame: Up to 72 hours postdose
Alternative Pathway Activity As Measured By Wieslab Assay
Time frame: Up to 72 hours postdose
Change From Baseline In Plasma Bb Fragment Of Complement Factor B Concentration
Time frame: Baseline, Up to 72 hours postdose
Change From Baseline In Complement Factor D Concentration
Time frame: Baseline, Up to 72 hours postdose
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