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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: Completed Phase 1 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT03227471 is a Phase 1 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 225 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (275% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT03227471 record still lists
NCT03227471 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (275% higher).
The record links to 0 conditions, and to 5 interventions - of which Matched Placebo is the first listed.
NCT03227471 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03227471's enrollment target sits among peer trials
225 223rd of 2000 higher than 1,774 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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