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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01768663
• Date of registration: 11/01/2013
• Prospective Registration: No
• Primary sponsor: Vertex Pharmaceuticals Incorporated
• Public title: 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
• Scientific title: A Phase 1, Open-Label Study to Examine the Effect of Ciprofloxacin, Itraconazole, and Rifampin on the Pharmacokinetics of Lumacaftor in Combination With Ivacaftor in Healthy Adult Subjects
• Date of first enrolment: January 2013
• Target sample size: 80
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01768663
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Ciprofloxacin

Drug: Rifampin

Drug: Ivacaftor

Drug: Itraconazole

Drug: Lumacaftor

Primary Outcome(s)

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 1-3: 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]

Secondary Outcome(s)

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]

Secondary ID(s)

VX12-809-009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors