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

Phase 1CompletedNCT02040597

Chiesi Farmaceutici S.p.A.42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Beclometasone/Formoterol/GlycopyrrolateDRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Biovirtus Research Site

Nadarzyn, Mokra 7, Poland

Medical University in Lodz

Lodz, Ul. Kopcińskiego 22, Poland

Outcomes

Primary Outcomes

Glycopyrrolate area under the curve (AUC)

AUC until the last quantifiable concentration (AUCt)

Time frame: over 72 h after single administration

Secondary Outcomes

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

Time frame: 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

Time frame: over 24 h after single administration

BDP pharmacokinetic parameters in plasma

AUCt, AUCinf, Cmax, tmax, half-life

Time frame: over 24 h after single administration

Urine Glycopyrrolate excretion (Ae)

Time frame: over 72 h after single administration

Urine formoterol excretion (Ae)

Time frame: 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

Time frame: A period of 3 to 7 weeks (from screening visit to follow-up phone call)

Vital signs

systolic and diastolic blood pressure

Data from ClinicalTrials.gov

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