A single oral dose study to investigate the PK and safety of olorofim in subjects with severe renal impairment compared to subjects with normal renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
Single oral dose
Omega Research
Orlando, Florida, United States
Area Under the Plasma Concentration-Time Curve From Time Zero to the time of the last quantifiable concentration (AUC 0-t)
Time frame: 0-96 hours
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0-96 hours
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: 0-96 hours
Apparent Elimination Half Life (t1/2)
Time frame: 0-96 hours
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf)
Time frame: 0-96 hours
Number of Participants With Treatment-Emergent Adverse Events
Time frame: 10 days
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