Summary
This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and ivacaftor (IVA) in participants 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del (F/F).
Conditions
Cystic Fibrosis
Recruitment Status
Completed
Eligibility Criteria
Key Inclusion Criteria:
Participants 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 participants
Solid organ or hematological transplantation
Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention
Intervention Type
Intervention Name
Drug
LUM
Drug
IVA
Phase
Phase 3
Gender
All
Min Age
12 Months
Max Age
23 Months
Download Date
January 6, 2023
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: