Trials / Completed
CompletedNCT02953314
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)
A Phase 3, Open Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 83 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 6 Years – 11 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3, 2-part (Part A and Part B), open label, multicenter study evaluating the pharmacokinetic (PK), safety, and tolerability of multiple doses of tezacaftor (TEZ) in combination with ivacaftor (IVA) in subjects 6 through 11 years of age with CF who are homozygous or heterozygous for the F508del- CF transmembrane conductance regulator protein (CFTR) mutation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TEZ | |
| DRUG | TEZ/IVA | |
| DRUG | IVA |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2018-09-01
- Completion
- 2018-09-01
- First posted
- 2016-11-02
- Last updated
- 2020-03-04
- Results posted
- 2019-12-05
Locations
33 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02953314. Inclusion in this directory is not an endorsement.