NCT05830071

A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)

A Randomized, Double-blind, Positive and Placebo-controlled, Single-dose, Crossover Study of the Effects of CHF5993 pMDI (BDP/FF/GB) at the Proposed Therapeutic and Supratherapeutic Doses, on the Cardiovascular Safety in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The main purpose of this study is to evaluate the effect of a single supratherapeutic dose of inhaled BDP/FF/GB on cardiovascular safety. The secondary purposes of the study are to: 1) evaluate the effect of a single supratherapeutic dose of inhaled BDP/FF/GB and GB on cardiovascular safety; 2) establish assay sensitivity by demonstrating the effect of a single oral dose of 400 mg moxifloxacin on cardiovascular safety; 3) determine the pharmacokinetics (PK) of single, inhaled therapeutic and supratherapeutic BDP/FF/GB doses and supratherapeutic GB dose; 4) determine if there is a relationship between the duration of the QTc intervals and the plasma concentrations of the B17MP (beclomethasone 17monopropionate active metabolite of BDP), FF and GB following the administration of BDP/FF/GB and GB pMDIs; 5) generate additional safety and tolerability information.

Conditions

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	CHF5993	BDP/FF/GB 100/6/12.5 μg pMDI
DRUG	CHF5259	GB 12.5 μg pMDI
DRUG	Moxifloxacin 400mg	400 mg Oral Tablets
DRUG	CHF5993 Placebo	placebo pMDI

Timeline

• Start date: 2023-03-29
• Primary completion: 2023-10-13
• Completion: 2023-10-13
• First posted: 2023-04-26
• Last updated: 2024-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study