Renal Impairment study of GBT021601.
This is a Phase 1, two-part, non-randomized, open-label, parallel group study to evaluate the PK, safety, and tolerability of GBT021601 following a single dose administration in adult participants with RI.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Oral
Orange County Research Center
Lake Forest, California, United States
Orange County Research Center
Tustin, California, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
Nucleus Network
Saint Paul, Minnesota, United States
Concentration of GBT021601 in whole blood and plasma
To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment (RI)
Time frame: Up to 112 Days
Single-dose PK parameters
To evaluate the single-dose whole blood and plasma PK of GBT021601 in participants with renal impairment
Time frame: Up to 112 Days
Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs
To evaluate the safety and tolerability of single dose GBT021601 in participants with renal impairment
Time frame: Up to 112 Days
Incidence of treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory assessments, electrocardiograms (ECGs), and vital signs
To evaluate the safety and tolerability of GBT021601 in ESRD participants receiving IHD following a single dose
Time frame: Up to 112 Days
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