A Phase 3 2-part Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis Homozygous for F508del

Study Overview

This study is being done to learn more about the safety and effects of the combination of Lumacaftor (LUM) and Ivacaftor (IVA) in patients with Cystic Fibrosis between 1 to less than 2 years of age.

Study Description

The purpose of this study is to evaluate the PK of lumacaftor (LUM) and ivacaftor (IVA) in subjects 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del.

Additional Information

Participants will be paid for their participation.


  • IRB Number: 1806061910
  • Research Study Identifier: TX9369
  • Principal Investigator: Clement Ren, MD

Recruitment Status

Open

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