The primary purpose of this study is to estimate the effect of moderate or mild hepatic impairment on the pharmacokinetic (PK) profile of a single oral dose of 20 mg vorasidenib in participants with hepatic impairment relative to healthy matched control participants with normal hepatic function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Administered orally as tablets.
American Research Corporation
San Antonio, Texas, United States
Maximum Observed Plasma Concentration (Cmax) of Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t) for Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC From Time 0 Extrapolated to Infinity (AUC0-inf) for Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Apparent Terminal Elimination Half-life (t1/2) of Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Apparent Oral Clearance (CL/F) for Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Apparent Volume of Distribution (Vz/F) of Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Area Under the Unbound Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t,u) for Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
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Area Under the Unbound Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf,u) for Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Maximum Observed Unbound Plasma Concentration (Cmax,u) of Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Cmax of Metabolite AGI-69460
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Tmax of Metabolite AGI-69460
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC0-t for Metabolite AGI-69460
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC0-inf for Metabolite AGI-69460
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Number of Participants With Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
Time frame: Up to end of study [EOS] (up to approximately 29 days)
Number of Participants With Abnormalities in Laboratory Parameters
Clinical laboratory assessments will include hematology, serum chemistry, coagulation, and urinalysis.
Time frame: Up to EOS (up to approximately 29 days)
Number of Participants With Abnormalities in Vital Signs
Systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature will be assessed.
Time frame: Up to EOS (up to approximately 29 days)
Number of Participants With Abnormalities in 12-Lead Electrocardiogram (ECG) Results
Time frame: Up to EOS (up to approximately 29 days)
Number of Participants With Abnormalities in Physical Examination Findings
Time frame: Up to EOS (up to approximately 29 days)