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Drug & research development » Clinical trials » 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

Clinical Trials gov number: NCT02015507

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Purpose: 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.

Phase: 1

Type: Interventional, non-randomized, open-label, crossover assignment

Study sponsor: Vertex Pharmaceuticals Incorporated

  • 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

Intervention
Ivacaftor, VX-661, ciprofloxacin

Geographical Location
No contacts or locations provided

Number of Participants
≤50 (18-55 years)

Primary Endpoint

  • PK parameters of ivacaftor and metabolites following concomitant dosing with ciprofloxacin relative to ivacaftor administered alone (Day 7 and Day 14)
  • 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 (Day 10, Day 20)

Secondary Endpoint

  • PK parameters of ivacaftor and metabolites when administered in combination with VX-661, with and without concomitant ciprofloxacin (Day 10, Day 20)
  • Safety and tolerability, as assessed by adverse events (AEs), vital signs, ECGs and laboratory assessments (Day 1 -21 for Cohort 1, Day1 – Day 34  for Cohort 2)

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  • Active Comparator: Cohort 1

Participants in Cohort 1 will be administered ivacaftor alone followed by ivacaftor with concomitant 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

View Trial Results