This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of ALXN2050 in order to provide dosing recommendations for future indications in individuals with impaired renal function.
The study will initiate (Part 1) with participants with severe impaired renal function (Cohort 1) and their matched healthy control participants (Cohort 4). Following data review, the study may proceed (Part 2) with participants with moderate (Cohort 2) and mild (Cohort 3) impaired renal function if deemed necessary.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
40
ALXN2050 (120 milligrams) will be administered orally twice daily on Days 1 through 3, with an additional dose (120 milligrams) administered orally on the morning of Day 4.
Clinical Trial Site
Hialeah, Florida, United States
Clinical Trial Site
Orlando, Florida, United States
Area Under The Concentration-time Curve From Time 0 To The 12-hour Time Point (AUC0-12) Of Plasma ALXN2050 After Steady-state
Time frame: Up to 72 hours postdose
Area Under The Concentration-time Curve Calculated To The Last Observable Concentration At Time t (AUCt) Of Plasma ALXN2050 After Steady-state
Time frame: Up to 72 hours postdose
Maximum (Peak) Steady-state Plasma Concentration (Cmax,ss) Of Plasma ALXN2050
Time frame: Up to 72 hours postdose
Time To Reach Maximum (Peak) Plasma Concentration Following ALXN2050 Administration At Steady-state (Tmax,ss)
Time frame: Up to 72 hours postdose
Change From Baseline In Complement Factor D Concentration At 24, 48, And 72 Hours Postdose
Time frame: Baseline, 24, 48, and 72 hours postdose
Change From Baseline In Plasma b Fragment Of Complement Factor B Concentration
Time frame: Baseline, up to 72 hours postdose
Change From Baseline In Complement Alternative Pathway Activity
Time frame: Baseline, up to 72 hours postdose
Number Of Participants Receiving ALXN2050 With Treatment-emergent Adverse Events
Time frame: Day 1 (postdose) through follow-up (30 [+/- 2] days after last study drug administration)]
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