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



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:2/6/2019
Start Date:August 23, 2018
End Date:September 2020
Contact:Medical Information
Email:medicalinfo@vrtx.com
Phone:617-341-6777

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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

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.
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