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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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ivacaftor
VX-661
ciprofloxacin
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Cohort 1

    Cohort 2

    Arm Description

    participants in Cohort 1 will be administered ivacaftor alone followed by ivacaftor with concomitant ciprofloxacin.

    Participants in Cohort 2 will be administered VX-661 in combination with ivacaftor followed by VX-661 in combination with ivacaftor and concomitant ciprofloxacin

    Outcomes

    Primary Outcome Measures

    PK parameters of ivacaftor and metabolites following concomitant dosing with ciprofloxacin relative to ivacaftor administered alone
    PK Parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC),
    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
    PK parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC),

    Secondary Outcome Measures

    PK parameters of ivacaftor and metabolites when administered in combination with VX-661, with and without concomitant ciprofloxacin
    PK Parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC),
    Safety and tolerability, as assessed by adverse events (AEs), vital signs, ECGs and laboratory assessments

    Full Information

    First Posted
    December 9, 2013
    Last Updated
    March 25, 2014
    Sponsor
    Vertex Pharmaceuticals Incorporated
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02015507
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    February 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Vertex Pharmaceuticals Incorporated

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cystic Fibrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort 1
    Arm Type
    Active Comparator
    Arm Description
    participants in Cohort 1 will be administered ivacaftor alone followed by ivacaftor with concomitant ciprofloxacin.
    Arm Title
    Cohort 2
    Arm Type
    Experimental
    Arm Description
    Participants in Cohort 2 will be administered VX-661 in combination with ivacaftor followed by VX-661 in combination with ivacaftor and concomitant ciprofloxacin
    Intervention Type
    Drug
    Intervention Name(s)
    ivacaftor
    Intervention Type
    Drug
    Intervention Name(s)
    VX-661
    Intervention Type
    Drug
    Intervention Name(s)
    ciprofloxacin
    Primary Outcome Measure Information:
    Title
    PK parameters of ivacaftor and metabolites following concomitant dosing with ciprofloxacin relative to ivacaftor administered alone
    Description
    PK Parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC),
    Time Frame
    Day 7, Day 14
    Title
    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
    Description
    PK parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC),
    Time Frame
    Day 10, Day 20
    Secondary Outcome Measure Information:
    Title
    PK parameters of ivacaftor and metabolites when administered in combination with VX-661, with and without concomitant ciprofloxacin
    Description
    PK Parameters - maximum observed plasma concentrations (Cmax) and area under the concentration versus time curve (AUC),
    Time Frame
    Day 10, Day 20
    Title
    Safety and tolerability, as assessed by adverse events (AEs), vital signs, ECGs and laboratory assessments
    Time Frame
    Day 1 through Day 21 (cohort 1) or Day 34 (cohort2)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Vertex Pharmaceutical Incorporated
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    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

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