This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
23
Unnamed facility
Prague, Czechia
Unnamed facility
Bratislava, Slovakia
Lumacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F
Time frame: 16 days
Ivacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F
Time frame: 16 days
Lumacaftor metabolites pharmacokinetic parameters, including Cmax and AUC
Time frame: 16 days
Ivacaftor metabolites pharmacokinetic parameters including Cmax, tmax, AUC
Time frame: 16 days
Safety and tolerability as mentioned by adverse events, clinical laboratory values, standard electrocardiograms, Vital signs and pulse oximetry
Time frame: 21 days
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