The purpose of this study is to evaluate the pharmacokinetics and safety of multiple doses of VX-584 in participants with mild or moderate hepatic impairment as compared to matched healthy controls.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
Tablets for oral administration.
Division of Clinical Pharmacology, University of Miami
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Oklahoma, United States
Maximum Observed Plasma Concentration (Cmax) of VX-548
Time frame: Day 1 to Day 31
Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548
Time frame: Day 1 to Day 31
Time Taken for VX-548 to Reach Maximum Concentration (tmax)
Time frame: Day 1 to Day 31
Time Required for Plasma Concentration of VX-548 to Reduce to Half (t1/2)
Time frame: Day 1 to Day 31
Apparent Volume of Distribution of VX-548 (Vz/F)
Time frame: Day 1 to Day 31
Apparent Clearance of VX-548 (CL/F)
Time frame: Day 1 to Day 31
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to the Last Measured Concentration (AUC0-last) of VX-548
Time frame: Day 1 to Day 31
Maximum Observed Plasma Concentration (Cmax) of VX-548 Metabolite
Time frame: Day 1 to Day 31
Area Under the Plasma Concentration Versus Time Curve During a Dosing Interval (AUCtau) of VX-548 Metabolite
Time frame: Day 1 to Day 31
Time Taken for VX-548 metabolite to Reach Maximum Concentration (tmax)
Time frame: Day 1 to Day 31
Time Required for Plasma Concentration of VX-548 Metabolite to Reduce to Half (t1/2)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 to Day 31
Apparent Volume of Distribution of VX-548 Metabolite (Vz/F)
Time frame: Day 1 to Day 31
Apparent Clearance of VX-548 Metabolite (CL/F)
Time frame: Day 1 to Day 31
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to the Last Measured Concentration (AUC0-last) of VX-548 Metabolite
Time frame: Day 1 to Day 31
Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma
Time frame: Day 14: Up to 24 hours Post-dose
Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite
Time frame: Day 14: Up to 24 hours Post-dose
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Day 42