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CompletedNCT02015507Updated Mar 26, 2014

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

A Phase 1 interventional study of ivacaftor and VX-661 in Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-26.

Sponsored by Vertex Pharmaceuticals Incorporated · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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

02

Conditions studied

  • Cystic Fibrosis

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03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 34 is close to the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Vertex Pharmaceuticals Incorporated is the lead sponsor of 243 studies on the registry; 19 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 49 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    Cohort 1

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

    Drug: ivacaftor · Drug: ciprofloxacin

  • Experimental
    Cohort 2

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

    Drug: ivacaftor · Drug: VX-661 · Drug: ciprofloxacin

Interventions

  • Drugivacaftor
  • DrugVX-661
  • Drugciprofloxacin
06

What researchers measure

Primary outcomes

  1. 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),

    Time frame: Day 7, Day 14

  2. 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),

    Time frame: Day 10, Day 20

Secondary outcomes

  1. 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),

    Time frame: Day 10, Day 20

  2. 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)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02015507
Lead sponsor
Vertex Pharmaceuticals Incorporated
Responsible party
Sponsor
First posted
Dec 19, 2013
Start date
Jan 2014
Primary completion
Feb 2014
Completion
Feb 2014
Last update
Mar 26, 2014

Study contacts

Medical Monitor
study director · Vertex Pharmaceutical Incorporated

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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