Cystic Fibrosis
Conditions
Brief summary
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.
Interventions
DRUGLumacaftor
tablet, 200mg taken every 12 hours
DRUGIvacaftor
tablet, 250mg taken every 12 hours
DRUGCiprofloxacin
750 mg taken every 12 hours
DRUGItraconazole
200mg taken once daily
DRUGRifampin
600mg taken once daily
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects must be between the ages of 18 and 55 years, inclusive * Body mass index (BMI) of 18 to 31 kg/m2, inclusive, and a total body weight \>50 kg.
Exclusion criteria
* History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject. This may include, but is not limited to, a history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; history or presence of clinically significant pathology; or history of mental disease. * History of febrile illness within 5 days before the first dose. * History of Gilbert's syndrome * Abnormal renal function as defined at screening * Blood donation of approximately 1 pint (500 mL) within 56 days before study drug administration * Treatment with an investigational drug within 30 days or 5 half-lives (or as determined by the local requirements, whichever is longer) preceding the first dose of study drug * Known hypersensitivity or prior adverse reaction to ciprofloxacin, or any member of the quinolone class of antimicrobial agents (Cohort 1 only); itraconazole, or to any of the other azoles (Cohort 2 only); rifampin, or to any of the rifamycins (Cohort 3 only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | up to 24 days |
| Cohort 4: Change in lung function from before treatment with lumacaftor/ivacaftor to after treatment with lumacaftor/ivacaftor. | up to 21 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 | up to 31 days |
| Cohort 4: PK parameters, including Cmax of lumacaftor/ivacaftor, and lung function | 16 days |
Countries
United States
Outcome results
None listed