The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of GBT440 compared with placebo in healthy subjects and subjects with sickle cell disease (SCD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
133
Guy's Hospital
London, United Kingdom
Safety, as assessed by frequency and severity of adverse events (AEs), and changes in vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments as compared to baseline
Time frame: 30 - 118 days
Blood and plasma area under the concentration time curve (AUC) of GBT440
Time frame: 30 - 118 days
Blood and plasma maximum concentration (Cmax) of GBT440
Time frame: 30 - 118 days
Blood and plasma time to maximum concentration (Tmax) of GBT440
Time frame: 30 - 118 days
Percentage of hemoglobin occupied or modified by GBT440
Time frame: 30 days
Change from baseline in heart rate and pulse oximetry following exercise testing in healthy volunteers
Time frame: 30 days
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