drugset / Trial / NCT05830071
A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)
RandomizedCrossoverTriple-blindBasic science
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.
Timeline
- Start
- 2023-03-29
- Primary completion
- 2023-10-13
- Completion
- 2023-10-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Formoterol | Other / unclassified | 6 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 48 ug | Inhaled |
| Subject | Glycopyrronium | Unknown | 12.5 ug | Inhaled |
| Subject | Glycopyrronium | Unknown | 100 ug | Inhaled |
| Comparator | Moxifloxacin | Small molecule | 400 mg | Oral |
| Subject | beclomethasone dipropionate | Other / unclassified | 100 ug | Inhaled |
| Subject | beclomethasone dipropionate | Other / unclassified | 800 ug | Inhaled |