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
PHASE2
Gender
ALL
Min Age
18 Years
Max Age
N/A
Download Date
2022-01-25
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: