To evaluate the effect of ciprofloxacin on the pharmacokinetics (PK) of ivacaftor and on the pharmacokinetics of VX-661 when administered in combination with ivacaftor
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
PK parameters of ivacaftor and metabolites following concomitant dosing with ciprofloxacin relative to ivacaftor administered alone
PK Parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC),
Time frame: Day 7, Day 14
PK parameters of VX-661 and metabolites when dosed in combination with ivacaftor and concomitant ciprofloxacin relative to VX-661 administered in combination with ivacaftor
PK parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC),
Time frame: Day 10, Day 20
PK parameters of ivacaftor and metabolites when administered in combination with VX-661, with and without concomitant ciprofloxacin
PK Parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC),
Time frame: Day 10, Day 20
Safety and tolerability, as assessed by adverse events (AEs), vital signs, ECGs and laboratory assessments
Time frame: Day 1 through Day 21 (cohort 1) or Day 34 (cohort2)
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