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
Completed · Phase 1
Conditions studied: Cystic Fibrosis
In brief
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.
Key facts
- Study ID
- NCT01768663
- Run by
- Vertex Pharmaceuticals Incorporated
- People needed
- 80
- Starts
- 2013-01-01
- Last updated by the study team
- 2013-11-15
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Study site — Evansville, Indiana, United States
Full record on ClinicalTrials.gov
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