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NCT03227471 · ClinicalTrials.gov registry record · Phase 1
A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
A Phase 1 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 225
- Enrollment target
NCT03227471 is a Phase 1 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 225 participants.
The verdict
NCT03227471, a Phase 1 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 225 participants
- Enrollment target
Study Summary
This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).
Interventions
- DRUG Matched Placebo
- DRUG IVA
- DRUG TEZ/IVA
- DRUG TEZ
- DRUG VX-445
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2017-01-23 |
| Est. Completion | 2018-03-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03227471
The ClinicalTrials.gov registry entry for NCT03227471 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Matched Placebo is the first listed.
NCT03227471 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03227471 about?
NCT03227471 is a clinical study titled "A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis". This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regu...
What is the current status of trial NCT03227471?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 225 participants. The study started on 2017-01-23. Estimated completion is 2018-03-27.
What interventions are being tested in trial NCT03227471?
The interventions under investigation include: Matched Placebo (DRUG), IVA (DRUG), TEZ/IVA (DRUG), TEZ (DRUG), VX-445 (DRUG).
Who is sponsoring clinical trial NCT03227471?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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