Vertex Pharmaceuticals Vx18-561-101 Study In Patients With Cystic Fibrosis
Posted Date: Jun 19, 2019
- Investigator: Maria Indihar
- Specialties:
- 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
Criteria:
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.
Keywords:
Cystic Fibrosis
For More Information:
Nicole Hummel
513-558-7036
nicole.hummel@uc.edu