A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects
Status and phase
Completed
Phase 1
Conditions
Cystic Fibrosis
Treatments
Drug: Ivacaftor
Drug: Rifampin
Drug: Itraconazole
Drug: Ciprofloxacin
Drug: Lumacaftor
Details and patient eligibility
About
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.
Enrollment
80 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
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)
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
80 participants in 4 patient groups
Treatment Group (Cohort 1)
Experimental group
Description:
Subjects will take lumacaftor in combination with ivacaftor for 14 days. Beginning on Day 15, subjects will take lumacaftor in combination with ivacaftor and ciprofloxacin through Day 21.
Treatment:
Drug: Lumacaftor
Drug: Ciprofloxacin
Drug: Ivacaftor
Treatment Group (Cohort 2)
Experimental group
Description:
Subjects will take lumacaftor in combination with ivacaftor for 14 days. Beginning on Day 15, subjects will take lumacaftor in combination with ivacaftor and itraconazole through Day 21.
Treatment:
Drug: Lumacaftor
Drug: Itraconazole
Drug: Ivacaftor
Treatment Group (Cohort 3)
Experimental group
Description:
Subjects will take lumacaftor in combination with ivacaftor for 14 days. Beginning on Day 15, subjects will take lumacaftor in combination with ivacaftor and rifampin through Day 24.
Treatment:
Drug: Lumacaftor
Drug: Rifampin
Drug: Ivacaftor
Treatment Group (Cohort 4)
Experimental group
Description:
Subjects will take a single dose of lumacaftor in combination with ivacaftor on 3 occasions separated by 7 days.
Treatment:
Drug: Lumacaftor
Drug: Ivacaftor
Trial contacts and locations
1
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2024 Veeva Systems