A Phase 1/2 Study of VX-121 in Subjects With Cystic Fibrosis and in Subjects without Cystic Fibrosis

Details

Therapeutic category
Restore CFTR Function
Trial status
Completed Participating Centres
Phase
Phase I/II

Full title

A Phase 1/2 Study of VX-121 in Subjects With Cystic Fibrosis and in Subjects without Cystic Fibrosis

Phase 1/2 safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of VX-121
Trial Reference Number
111537
Trial type
Medication
Intervention
CFTR Modulators (Ivacaftor / Tezacaftor)
Recruitment target
132
Last edited date
26/06/2019
CF sponsor
Vertex Pharmaceuticals Incorporated
CF sponsor type
Commercial

Who can take part?

Age
18+
Top inclusion criteria
  • One copy of F508del mutation
  • Body weight ≥35 kg
  • Must be able to produce a sweat sample at screening
Top exclusion criteria
  • An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for sinopulmonary disease
  • History of cirrhosis (liver injury)
  • Risk factors for Torsade de Pointes (abnormal heart rhythm) and other ventricular arrhythmias (abnormal heartbeats)

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