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)