This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and ivacaftor (IVA) in subjects 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del (F/F).
Key Inclusion Criteria:
Subjects will be 1 to less than 2 years of age on Day 1 of the relevant part of the study.
Homozygous for F508del (F/F).
Key Exclusion Criteria:
Any clinically significant laboratory abnormalities at the Screening Visit that would interfere with the study assessments or pose an undue risk for the subject.
Solid organ or hematological transplantation.
Other protocol defined Inclusion/Exclusion criteria may apply.
November 29, 2021
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
For more information and to contact the study team: