A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function
- Registration Number
- NCT05674474
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: Normal Hepatic Function Vorasidenib Participants with normal hepatic function will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1. Group B: Moderate or Mild Hepatic Impairment Vorasidenib Stage 1: Participants with moderate hepatic impairment (Child-Pugh \[C-P\] Class B, score of 7 to 9) will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1. Stage 2: Participants with mild hepatic impairment (C-P Class A, score of 5 to 6) will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1. Stage 2 will be conducted if a clinically meaningful increase in exposure of vorasidenib is observed in participants with moderate hepatic impairment in Stage 1.
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of Vorasidenib 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 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 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 Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
- Secondary Outcome Measures
Name Time Method Apparent Terminal Elimination Half-life (t1/2) of Vorasidenib Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose Apparent Oral Clearance (CL/F) for Vorasidenib 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 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 Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose AUC0-t for Metabolite AGI-69460 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 Extrapolated to Infinity (AUCinf,u) for Vorasidenib 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 Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose Cmax of Metabolite AGI-69460 Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose Tmax of Metabolite AGI-69460 Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose AUC0-inf for Metabolite AGI-69460 Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose Number of Participants With Adverse Events (AEs) Up to end of study [EOS] (up to approximately 29 days) 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.
Number of Participants With Abnormalities in Physical Examination Findings Up to EOS (up to approximately 29 days) Number of Participants With Abnormalities in Laboratory Parameters Up to EOS (up to approximately 29 days) Clinical laboratory assessments will include hematology, serum chemistry, coagulation, and urinalysis.
Number of Participants With Abnormalities in Vital Signs Up to EOS (up to approximately 29 days) Systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature will be assessed.
Number of Participants With Abnormalities in 12-Lead Electrocardiogram (ECG) Results Up to EOS (up to approximately 29 days)
Trial Locations
- Locations (1)
American Research Corporation
🇺🇸San Antonio, Texas, United States