The purpose of this study is to evaluate whether blood levels of sonrotoclax after administration of a tablet for oral suspension are similar to those observed with the current sonrotoclax tablet. In addition, this study evaluates the effect of food on the absorption of sonrotoclax after administration of the tablet for oral suspension and the resulting blood levels of sonrotoclax.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
12
Administered orally
Administered orally
Linear Early Phase
Joondalup, Western Australia, Australia
RECRUITINGArea under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) for Sonrotoclax
Time frame: Approximately 20 days
Area under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) for Sonrotoclax
Time frame: Approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Sonrotoclax
Time frame: Approximately 20 days
Time of the Maximum Observed Concentration (Tmax) for Sonrotoclax
Time frame: Approximately 20 days
Apparent Terminal Elimination Half-life (t1/2) for Sonrotoclax
Time frame: Approximately 20 days
Apparent Total Clearance (CL/F) for Sonrotoclax
Time frame: Approximately 20 days
Apparent Volume of Distribution (Vz/F) for Sonrotoclax
Time frame: Approximately 20 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to approximately 47 days
Number of Participants with Abnormal Clinically Significant Electrocardiogram (ECG) Values
Clinically significant ECG values include a prolonged QT interval, presence of atrial fibrillation or other significant arrhythmia.
Time frame: Up to approximately 47 days
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Number of Participants with Clinically Significant Vital Signs Measurements
Vital signs include pulse rate, body temperature, and blood pressure.
Time frame: Up to approximately 47 days