The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 and its metabolite in participants with severe or moderate renal impairment and healthy participants.
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
TREATMENT
Masking
NONE
Enrollment
38
Tablets for oral administration.
Infigo Clinical Research
DeLand, Florida, United States
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
GCP Research
St. Petersburg, Florida, United States
Genesis Clinical Research
Tampa, Florida, United States
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
Time frame: Day 1 to Day 14
Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite
Time frame: Day 1 to Day 14
Apparent Clearance of VX-548
Time frame: Day 1 to Day 14
Apparent Renal Clearance of VX-548 and its Metabolite (CLr)
Time frame: Day 1 to Day 14
Apparent Non-Renal Clearance of VX-548
Time frame: Day 1 to Day 14
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 to Day 23
Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma
Time frame: Day 1 to Day 2
Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite
Time frame: Day 1 to Day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Elixia, Phase 1 Clinical Site
Tampa, Florida, United States
Southwest Houston Research, Ltd
Houston, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States