The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.
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
January 25, 2022
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
For more information and to contact the study team: