This study is being done to learn about etavopivat, a once a day medicine taken by mouth in adolescents with sickle cell disease. The main goals are to study safety and how long etavopivat stays in the bloodstream, while also studying if there are benefits from taking etavopivat. Eligible participants who enter the study will start a 96-week treatment period. At the end of the 96 weeks, participants will have an end of study visit that occurs 4 weeks later. The participants will receive etavopivat every day throughout the treatment period.
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Single-dose: maximum plasma concentration (Cmax)
Timeframe: During the 24-week primary treatment period
Single-dose: area under the plasma concentration time curve from dosing (time 0) to time t ((AUC)0-t)
Timeframe: During the 24-week primary treatment period
Single-dose: area under the plasma concentration time curve from zero to time infinity (AUC0-inf)
Timeframe: During the 24-week primary treatment period
Steady-state maximum plasma concentration (Cmax,ss)
Timeframe: During the 24-week primary treatment period
Steady-state area under the concentration time curve over the dosing interval (AUCtau,ss)
Timeframe: During the 24-week primary treatment period
Steady-state average plasma concentration (Cavg,ss)
Timeframe: During the 24-week primary treatment period
Steady-state minimum plasma concentration (Cmin,ss)
Timeframe: During the 24-week primary treatment period
Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs related to etavopivat
Timeframe: During the 24-week primary treatment period
Number of premature discontinuations
Timeframe: During the 24-week primary treatment period
Number of dose interruptions
Timeframe: During the 24-week primary treatment period
Number of dose reductions
Timeframe: During the 24-week primary treatment period