PF-Atlas › Clinical Trials › NCT02797132
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
LUM/IVA · Phase 3
Registry ID
NCT02797132
Phase
Phase 3
Status
Completed
Drug / intervention
LUM/IVA
Sponsor
Vertex Pharmaceuticals Incorporated
Start
2016-05
Enrollment
62
Locations
20
About this trial
This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study evaluating the pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of multiple doses of lumacaftor/ivacaftor (LUM/IVA) in subjects 2 through 5 years of age (inclusive) with cystic fibrosis (CF), homozygous for F508del. Subjects who participate in Part A may participate in Part B, if they meet the eligibility criteria.
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Medical disclaimer. This page summarizes public trial data for NCT02797132 for information only. It is not medical advice, an endorsement, or an offer to enroll. Confirm details on ClinicalTrials.gov and with a qualified physician.