Current Environment:

Warning

Recall Alert

There is a voluntary recall of some nasal sprays. Learn more

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:

Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del NCT03601637