NCT05431426

PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers

Open-label, Non-randomised, Parallel-group Study to Investigate the Pharmacokinetics, Safety and Tolerability Following Single Administration of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment in Comparison With Matched Healthy Control Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to obtain pharmacokinetics, safety and tolerability data after single administrations of CHF6001 in subjects with mild, moderate and severe renal impairment as well as healthy volunteers under the same setting.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	CH6001	CHF6001 will be administered using the NEXThaler® DPI device

Timeline

• Start date: 2022-07-29
• Primary completion: 2022-12-27
• Completion: 2022-12-27
• First posted: 2022-06-24
• Last updated: 2023-01-26

Locations

1 site across 1 country: Bulgaria