Summary
The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.
Conditions
Cystic Fibrosis
Recruitment Status
Completed
Eligibility Criteria
Key Inclusion Criteria:
Must have 1 of the following 9 CFTR mutations on at least 1 allele: G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D
On ivacaftor therapy
FEV1 value ≥40% and ≤100% of predicted mean for age, sex, and height
Key Exclusion Criteria:
History of clinically significant cirrhosis with or without portal hypertension
History of solid organ or hematological transplantation
Lung infection with organisms associated with a more rapid decline in pulmonary status
Other protocol defined Inclusion/Exclusion criteria may apply
Intervention
Intervention Type
Intervention Name
Drug
VX-561
Drug
IVA
Drug
Placebo
Drug
Placebo
Phase
Phase 2
Gender
All
Min Age
18 Years
Max Age
N/A
Download Date
January 25, 2022
Principal Investigator
N/A
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: