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NCT05830071 · ClinicalTrials.gov registry record · Phase 1
A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)
A Phase 1 study, sponsored by Chiesi Farmaceutici S.p.A..
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
NCT05830071 is a Phase 1 study that has completed, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 95 participants.
The verdict
NCT05830071, a Phase 1 study, has completed, sponsored by Chiesi Farmaceutici S.p.A..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the potential for cardiac repolarization, according to electrocardiographic monitoring (including QT and QTc intervals), of two dose levels of CHF5993 pMDI (beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB)) and of one dose of CHF5259 (GB) in healthy subjects compared to moxifloxacin and placebo.
Interventions
- DRUG Moxifloxacin 400mg
- DRUG CHF5993
- DRUG CHF5259
- DRUG CHF5993 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2023-03-29 |
| Est. Completion | 2023-10-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05830071
The ClinicalTrials.gov registry entry for NCT05830071 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Chiesi Farmaceutici S.p.A., which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Moxifloxacin 400mg is the first listed.
NCT05830071 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05830071 about?
NCT05830071 is a clinical study titled "A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)". The purpose of this study is to evaluate the potential for cardiac repolarization, according to electrocardiographic monitoring (including QT and QTc intervals), of two dose levels of CHF5993 pMDI (beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB)) and of one dose of...
What is the current status of trial NCT05830071?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2023-03-29. Estimated completion is 2023-10-13.
What interventions are being tested in trial NCT05830071?
The interventions under investigation include: Moxifloxacin 400mg (DRUG), CHF5993 (DRUG), CHF5259 (DRUG), CHF5993 Placebo (DRUG).
Who is sponsoring clinical trial NCT05830071?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
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