The primary purpose of this study is to assess the relative bioavailability of the mitapivat coated granule formulation compared to the tablet formulation following a single oral dose of mitapivat under fasted conditions in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Oral tablets
Oral coated granules
Covance Clinical Research Unit Inc.
Dallas, Texas, United States
Maximum Observed Concentration (Cmax) of Mitapivat Under Fasted Conditions
Time frame: Pre-dose and multiple time points post-dose (up to 72 hours)
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC0-t) of Mitapivat Under Fasted Conditions
Time frame: Pre-dose and multiple time points post-dose (up to 72 hours)
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) of Mitapivat Under Fasted Conditions
Time frame: Pre-dose and multiple time points post-dose (up to 72 hours)
Time to Reach Maximum Observed Concentration (Tmax) of Mitapivat Under Fasted Conditions
Time frame: Pre-dose and multiple time points post-dose (up to 72 hours)
Cmax of Mitapivat Under Fed Conditions
Time frame: Pre-dose and multiple time points post-dose (up to 72 hours)
AUC0-t of Mitapivat Under Fed Conditions
Time frame: Pre-dose and multiple time points post-dose (up to 72 hours)
AUC0-∞ of Mitapivat Under Fed Conditions
Time frame: Pre-dose and multiple time points post-dose (up to 72 hours)
Tmax of Mitapivat Under Fed Conditions
Time frame: Pre-dose and multiple time points post-dose (up to 72 hours)
Relative Bioavailability (Frel) Under Fasted and Fed Conditions
Time frame: Pre-dose and multiple time points post-dose (up to 72 hours)
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Area Under the Plasma Concentration-Time Curve from Time Zero to Twelve Hours (AUC0-12) of Mitapivat Under Fasted and Fed Conditions
Time frame: Pre-dose and multiple time points post-dose (up to 72 hours)
Apparent Plasma Terminal Elimination Half-life (t½) of Mitapivat Under Fasted and Fed Conditions
Time frame: Pre-dose and multiple time points post-dose (up to 72 hours)
Apparent Total Plasma Clearance (CL/F) of Mitapivat Under Fasted and Fed Conditions
Time frame: Pre-dose and multiple time points post-dose (up to 72 hours)
Apparent Volume of Distribution (Vz/F) of Mitapivat Under Fasted and Fed Conditions
Time frame: Pre-dose and multiple time points post-dose (up to 72 hours)
Apparent Terminal Elimination Rate Constant (λz) of Mitapivat Under Fasted and Fed Conditions
Time frame: Pre-dose and multiple time points post-dose (up to 72 hours)
Number of Participants With Adverse Event (AEs)
Time frame: Up to approximately 9 weeks
Number of Participants With AEs, Graded by Severity
Time frame: Up to approximately 9 weeks
Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values
Time frame: Up to approximately 9 weeks
Number of Participants With Clinically Significant Abnormal Findings for 12-lead Electrocardiogram (ECG) Parameters
Time frame: Up to approximately 9 weeks
Number of Participants With Clinically Significant Abnormal Findings for Vital Signs Parameters
Time frame: Up to approximately 9 weeks
Number of Participants With Clinically Significant Abnormal Physical Examination Findings
Time frame: Up to approximately 9 weeks