A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild, moderate, or severe renal impairment disease and healthy subjects with normal renal function.
Up to 40 adult subjects will be enrolled. Safety and PK assessments will be performed at selected time points throughout the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
Oral
University of Miami
Miami, Florida, United States
OCRC
Orlando, Florida, United States
Cmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
Maximum observed plasma concentration
Time frame: 28 days max
Tmax of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
Time frame: 28 days max
AUC of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
Time frame: 28 days max
T1/2 of GBT440 in subjects with severe, moderate, or mild renal impairment versus subjects with normal renal function
Time frame: 28 days max
Number of subjects with treatment-related Adverse events
Time frame: 28 days max
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