Vertex Pharmaceuticals Vx18-561-101 Study In Patients With Cystic Fibrosis
Posted Date: Jun 19, 2019
- Investigator: Maria Indihar
- Type of Study: Drug
A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis. Primary Objective • To evaluate the efficacy of VX-561 Secondary Objectives • To evaluate the pharmacodynamic (PD) effect of VX-561 • To evaluate the pharmacokinetics (PK) of VX-561, IVA, and relevant metabolites • To evaluate the safety and tolerability of VX-561 Investigational Drugs Active substance: VX-561 Activity: CFTR potentiator (increased Cl- secretion) Strength and route of administration: 50-mg and 25-mg VX-561 tablets for oral administration Active substance: IVA (VX-770) Activity: CFTR potentiator (increased Cl- secretion) Strength and route of administration: 150-mg film-coated tablet for oral administration Study Duration Including the Screening Period, each subject will participate in the study for approximately 20 weeks
Men And Women 18 Years Of Age Or Older With Cystic Fibrosis And Who Have A Gating Mutation And Were Previously Taking A Stable Dose Of Ivacaftor.
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