A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.

Study Overview
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Brief Summary
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The study is performed to characterize the pharmacokinetics of glycopyrrolate bromide after single administration of CHF 5993 pressurised Metered Dose Inhaler (pMDI) in subjects with different level of renal impairment in comparison with matching healthy volunteers. Moreover, the safety and tolerability of the study drug will be also evaluated.

Official Title
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Open-label, Non-randomized, Parallel-group Study to Investigate the Pharmacokinetics, Safety and Tolerability of a Single Dose of CHF 5993 pMDI in Subjects With Mild, Moderate and Severe Renal Impairment in Comparison With Matched Healthy Control Subjects.

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Beclometasone/Formoterol/Glycopyrrolate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers and Subjects with mild, moderate and severe renal impairment Exclusion Criteria: pregnant or lactating women positive HIV and hepatitis serology history of drug abuse history of hypersensitivity to the products used in the trial smokers respiratory disease such as asthma and COPD clinically relevant concomitant disease that may introduce a risk for the subjects'safety presence of kidney stones dialysis

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHF5993 pMDI<br>CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/25 mcg) 4 inhalations | Drug: Beclometasone/Formoterol/Glycopyrrolate<br> <br> * Other names: CHF 5993 pMDI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycopyrrolate area under the curve (AUC) | AUC until the last quantifiable concentration (AUCt) | over 72 h after single administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycopyrrolate other Pharmacokinetic parameters in plasma | AUC until 72 h post dose (AUC0-72h), AUC extrapolated to infinity (AUCinf), maximum plasma concentratio (Cmax), time to maximum plasma concentration (tmax), half-life, clearance | Over 72 h after single administration | 
| B17MP and Formoterol pharmacokinetic parameters in plasma | AUCt, AUC until 24 h post dose (AUC0-24h), AUCinf, Cmax, tmax, half-life, clearance | over 24 h after single administration | 
| BDP pharmacokinetic parameters in plasma | AUCt, AUCinf, Cmax, tmax, half-life | over 24 h after single administration | 
| Urine Glycopyrrolate excretion (Ae) |  | over 72 h after single administration | 
| Urine formoterol excretion (Ae) |  | Over 24 h after single administration | 
| Adverse events | This includes a period of 3 to 7 weeks (depending on duration of screening and follow-up periods), before and after the study drug administration | A period of 3 to 7 weeks (from screening visit to follow-up phone call) | 
| Vital signs | systolic and diastolic blood pressure | over 24 h after single administration | 
| Electrocardiogram (ECG) parameters | Heart rate (HR), time interval between ECG waves Q and T corrected for heart rate with Fridericia's formula (QTcF), time interval between the onset of the ECG wave P and the start of the QRS complex (PR), time interval between the beginning of Q wave and the termination of the S wave (QRS) | over 24 h after single administration |