Evaluate the safety and tolerability of VX-659 in healthy subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
163
Unnamed facility
Birmingham, United Kingdom
Unnamed facility
Cambridge, United Kingdom
Unnamed facility
Exeter, United Kingdom
Unnamed facility
Glasgow, United Kingdom
Safety and Tolerability assessments as determined by number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Time frame: from baseline up to Day 50
Maximum observed concentration (Cmax) of VX-659 and selected metabolites (μg/mL)
Time frame: from baseline up to Day 18
Cmax of TEZ and selected metabolites (μg/mL)
Time frame: from baseline up to Day 18
Cmax of IVA and selected metabolites (μg/mL)
Time frame: from baseline up to Day 18
Area under the concentration versus time curve during a dosing interval (AUCtau) of VX-659 and selected metabolites (μg,h/mL)
Time frame: from baseline up to Day 18
AUCtau of TEZ and selected metabolites (μg,h/mL)
Time frame: from baseline up to Day 18
AUCtau of IVA and selected metabolites (μg,h/mL)
Time frame: from baseline up to Day 18
Observed pre-dose concentration (Ctrough) of VX-659 and selected metabolites (μg/mL)
Time frame: from baseline up to Day 18
Ctrough of TEZ and selected metabolites (μg/mL)
Time frame: from baseline up to Day 18
Ctrough of IVA and selected metabolites (μg/mL)
Time frame: from baseline up to Day 18
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Leeds, United Kingdom
Unnamed facility
Liverpool, United Kingdom
Unnamed facility
London, United Kingdom
Unnamed facility
Manchester, United Kingdom
Unnamed facility
Newcastle upon Tyne, United Kingdom
Unnamed facility
Southampton, United Kingdom