Voxelotor Neurocognitive Function Study

Exclusion Criteria

• •1. Receiving chronic transfusion therapy.
• •2. Red blood cell (RBC) transfusion within 3 months before initiation of study drug or receives scheduled RBC transfusion therapy (also termed chronic, prophylactic, or preventive transfusion).
• •3. History of overt stroke including hemorrhagic stroke or transient ischemic attack (TIA) or spinal cord injury, magnetic resonance angiography (MRA)-defined vasculopathy, or magnetic resonance imaging (MRI)/transcranial doppler (TCD)-documented silent cerebral infarcts.
• •4. Congenital brain malformation, previously diagnosed severe developmental disability (eg, autism and/or intelligence quotient \[IQ\] \< 60, and/or severe attention deficit hyperactivity disorder \[ADHD\]), or impairment that would prevent the use of a computer tablet.
• •5. Participant is taking or has received voxelotor (Oxbryta®) within 90 days prior to the Screening Visit.
• •6. Surgery within 8 weeks before Day 1 or planned elective surgery during the study.
• •7. Anemia due to bone marrow failure (eg, myelodysplasia).
• •8. Absolute reticulocyte count (ARC) \< 100 × 10\^9/L.
• •9. Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 4× upper limit of normal (ULN).
• •10. Severe renal dysfunction (estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m\^2) or is on chronic dialysis.
• •11. Clinically significant bacterial, fungal, parasitic, or viral infection which requires therapy.
• •1. Patients with acute bacterial infection requiring antibiotic use should delay screening /enrollment until the course of antibiotic therapy has been completed.
• •2. Patients with known active hepatitis A, B, or C or who are known to be human immunodeficiency virus (HIV) positive.
• •12. Symptomatic coronavirus disease of 2019 (COVID-19) infection.
• •13. Females who are breast-feeding or pregnant.
• •14. History of hematopoietic stem cell transplant or gene therapy.
• •15. Participants taking concomitant medications such as sensitive cytochrome P450 (CYP)3A4 substrates with a narrow therapeutic range, or strong CYP3A4 inducers
• •16. Participated in another clinical trial of an investigational product (or medical device) within 30 days or 5 half-lives of date of informed consent, whichever is longer, or is currently participating in another trial of an investigational product (or medical device).
• •17. Medical, psychological, or behavioral condition that, in the opinion of the Investigator, would confound or interfere with evaluation of safety and/or efficacy of the study drug, prevent compliance with the study protocol; preclude informed consent; or, render the participant unable/unlikely to comply with the study procedures.