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

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: CH6001

• Registration Number: NCT05431426
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-24
• Study Start: 2022-07-29
• Primary Completion: 2022-12-27
• Study Completion: 2022-12-27
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild renal impaired subjects	CH6001	Administration of a single dose of CH6001 800 µg in mild renal impaired subjects.
Moderate renal impaired subjects	CH6001	Administration of a single dose of CH6001 800 µg in moderate renal impaired subjects.
Severe renal impaired subjects	CH6001	Administration of a single dose of CH6001 800 µg in severe renal impaired subjects.
Healthy volunteers	CH6001	Administration of a single dose of CH6001 800 µg in healthy volunteers.

Primary Outcome Measures

Name	Time	Method
Area under the Curve (AUC) of total plasma CHF6001	Over 240 hours after CHF6001 administration	Area under the plasma concentration versus time curve for total plasma CHF6001 after a single-dose of CHF6001
Maximum of Concentration (Cmax) of total plasma CHF6001	Over 240 hours after CHF6001 administration	Peak plasma concentration for total plasma CHF6001 after a single-dose of CHF6001

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameter (AUC0-72)	Over 240 hours after administration in blood	Area under plasma concentration from 0 to 72hours (AUC0-72) for CHF6001, CHF5956 and CHF6095
Pharmacokinetic parameter (AUC0-∞)	Over 240 hours after administration in blood	Area under plasma concentration from 0 to infinity(AUC0-∞) for CHF6001, CHF5956 and CHF6095
Pharmacokinetic parameter (AUCt)	Over 240 hours after administration in blood	Area under the plasma concentration versus time curve (AUCt) for CHF5956 and CHF6095
Pharmacokinetic parameter ( Cmax)	Over 240 hours after administration in blood	Peak Plasma Concentration (Cmax) for CHF6001 unbound plasma
Pharmacokinetic parameter (tmax)	Over 240 hours after administration in blood	Time of the maximum plasma concentration (tmax) for CHF6001, CHF5956 and CHF6095
Pharmacokinetic parameter (t1/2)	Over 240 hours after administration in blood	Terminal half-life (t1/2) for CHF6001, CHF5956 and CHF6095
Pharmacokinetic parameter (CL/F)	Over 240 hours after administration in blood	Apparent systemic clearance (CL/F) for CHF6001
Pharmacokinetic parameter (AUC0-240)	Over 240 hours after administration in blood	Area under plasma concentration from 0 to 240hours (AUC0-240) for CHF6001, CHF5956 and CHF6095
Pharmacokinetic parameter (Cmax)	Over 240 hours after administration in blood	Peak Plasma Concentration (Cmax) for CHF5956 and CHF6095

Trial Locations

Locations (1)

MC Comac Medical Ltd.; 🇧🇬 Sofia, Bulgaria