The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin, itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with ivacaftor as well as to evaluate the potential effects of lumacaftor in combination with ivacaftor on lung function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
tablet, 200mg taken every 12 hours
tablet, 250mg taken every 12 hours
750 mg taken every 12 hours
Unnamed facility
Evansville, Indiana, United States
Cohorts 1-3: PK parameters including Cmax, and AUC from time of dosing to time tau of lumacaftor and ivacaftor in the absence and presence of ciprofloxacin, itraconazole, and rifampin
Time frame: up to 24 days
Cohort 4: Change in lung function from before treatment with lumacaftor/ivacaftor to after treatment with lumacaftor/ivacaftor.
Time frame: up to 21 days
Cohorts 1-4: Safety and tolerability as measured by adverse events (AEs) and changes in laboratory test values (serum chemistry, hematology, coagulation, and urinalysis), vital signs, standard 12 lead electrocardiograms (ECGs), and spirometry
Time frame: up to 31 days
Cohort 4: PK parameters, including Cmax of lumacaftor/ivacaftor, and lung function
Time frame: 16 days
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200mg taken once daily
600mg taken once daily