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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

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Vertex Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: VX-661
Drug: ciprofloxacin
Drug: ivacaftor

Study type

Interventional

Funder types

Industry

Identifiers

NCT02015507
VX13-770-017

Details and patient eligibility

About

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

Enrollment

34 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Cohort 1
Active Comparator group
Description:
participants in Cohort 1 will be administered ivacaftor alone followed by ivacaftor with concomitant ciprofloxacin.
Treatment:
Drug: ciprofloxacin
Drug: ivacaftor
Cohort 2
Experimental group
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
Treatment:
Drug: VX-661
Drug: ciprofloxacin
Drug: ivacaftor

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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