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A Phase 1, Randomized, Double Blind, Placebo Controlled, Dose Escalation, and Bioavailability Study Evaluating the Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Subjects With Cystic Fibrosis (NCT03029455)

Evaluate the safety and tolerability of VX-659 in healthy subjects
  • Drug: VX-659
    • Drug: Tezacaftor
      • VX-661
      • TEZ
    • Drug: Ivacaftor
      • VX-770
      • IVA
    • Drug: VX-659 Matching Placebo
      • Drug: Triple Combination (TC) Matching Placebos
        Ages eligible for Study
        18 Years and older
        Genders eligible for Study
        Accepts Healthy Volunteers
        Accepts Healthy Volunteers
        Inclusion Criteria:
        • Healthy Volunteers: PARTS A, B, and C
        • Males and Females of non-childbearing potential.
        • Between the ages of 18 and 60 years inclusive
        • Healthy, as defined per protocol.
        • Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive
        • Body weight >50 kg CF Patients: PART D
        • Body weight ≥35 kg.
        • Males and Females of non-childbearing potential.
        • Sweat chloride value ≥ 60 mmol/L at screening.
        • Heterozygous for F508del and a minimal function CFTR mutation
        • Forced expiratory volume in 1 second (FEV1) ≥40% and ≤90% of predicted at screening
        Exclusion Criteria:
        • Healthy Volunteers: PARTS A, B, and C
        • History of any illness or any clinical condition that in the opinion of the investigator might confound the results of the study or pose additional risk to the subject.
        • Any condition possibly affecting drug absorption.
        • History of febrile illness within 14 days before the first study drug dose.
        • Glucose-6-phosphate dehydrogenase (G6PD) deficiency assessed at Screening. CF Patients: PART D
        • History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the subject.
        • History of cirrhosis with portal hypertension.
        • Risk factors for Torsade de Pointes.
        • G6PD deficiency assessed at Screening.
        • Abnormal Laboratory Values.
        • Lung infection with organisms associated with a more rapid decline in pulmonary status
        • History of solid organ or hematological transplantation.

        10 locations

        United Kingdom (10)
        • Not specified
          Birmingham, United Kingdom
        • Not specified
          Cambridge, United Kingdom
        • Not specified
          Exeter, United Kingdom
        • Not specified
          Glasgow, United Kingdom
        • Not specified
          Leeds, United Kingdom
        • Not specified
          Liverpool, United Kingdom
        • Not specified
          London, United Kingdom
        • Not specified
          Manchester, United Kingdom
        • Not specified
          Newcastle upon Tyne, United Kingdom
        • Not specified
          Southampton, United Kingdom
        31 October, 2016
        31 August, 2017
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