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
PHASE3
Gender
ALL
Min Age
12 Months
Max Age
23 Months
Download Date
2023-01-06
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: