Clinical trial NCT02015507: An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on Ivacaftor and VX-661 in Combination With Ivacaftor
Official title: An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on the Multiple-Dose Pharmacokinetics of Ivacaftor and on the Multiple-Dose Pharmacokinetics of VX-661 Administered in Combination With Ivacaftor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2013-12-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of ciprofloxacin on the pharmacokinetics (PK) of ivacaftor and on the pharmacokinetics of VX-661 when administered in combination with ivacaftor


Eligibility criteria: Inclusion Criteria:

* Willing and able to comply with scheduled visits, treatment plan, study restrictions,laboratory tests, contraception guidelines, and other study procedures
* Healthy subjects, as defined by no clinically relevant abnormalities identified by a detailed medical history and full physical examination, including blood pressure and heart rate measurement, standard 12-lead ECG, and clinical laboratory tests.
* Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive, and a total body weight \>50 kg
* Female subjects of childbearing potential must have a negative serum pregnancy test at screening and at the Day -1 Visit.

Exclusion Criteria:

* History of any illness, clinical condition, or other factor that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
* Inability to swallow capsules, or inadequate venous access.
* History of febrile illness within 5 days before the first study drug dose
* A screen positive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus 1 or 2 antibodies.
* For female subjects: Pregnant or nursing subjects and female subjects of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol. For male subjects: Subject has a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 120 days after the last study drug dose.
* Any condition possibly affecting drug absorption
* Abnormal renal function at screening

Primary outcomes:
measure: PK parameters of ivacaftor and metabolites following concomitant dosing with ciprofloxacin relative to ivacaftor administered alone
timeFrame: Day 7, Day 14
measure: PK parameters of VX-661 and metabolites when dosed in combination with ivacaftor and concomitant ciprofloxacin relative to VX-661 administered in combination with ivacaftor
timeFrame: Day 10, Day 20
Secondary outcomes:
measure: PK parameters of ivacaftor and metabolites when administered in combination with VX-661, with and without concomitant ciprofloxacin
timeFrame: Day 10, Day 20
measure: Safety and tolerability, as assessed by adverse events (AEs), vital signs, ECGs and laboratory assessments
timeFrame: Day 1 through Day 21 (cohort 1) or Day 34 (cohort2)
Other outcomes:
Locations:
Study officials:
affiliation: Vertex Pharmaceutical Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References: