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

NCT05830071 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2024-09-04

No results posted yet for this 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.

Conditions

  • Asthma
  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

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

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Ronald Goldwater, MDCM/M.SC(A) · PAREXEL Baltimore Early Phase Clinical Unit

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-29
Primary Completion
2023-10-13
Completion
2023-10-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05830071 on ClinicalTrials.gov