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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— TRIPLE10  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040597
• Other study ID #: CCD-05993AA1-10
• Secondary ID: 2013-002140-91
• Status: Completed
• Phase: Phase 1
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: October 2021
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Beclometasone/Formoterol/Glycopyrrolate

Locations

Country	Name	City	State
Poland	Medical University in Lodz	Lodz	Ul. Kopcinskiego 22
Poland	Biovirtus Research Site	Nadarzyn	Mokra 7

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycopyrrolate area under the curve (AUC)	AUC until the last quantifiable concentration (AUCt)	over 72 h after single administration
Secondary	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
Secondary	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
Secondary	BDP pharmacokinetic parameters in plasma	AUCt, AUCinf, Cmax, tmax, half-life	over 24 h after single administration
Secondary	Urine Glycopyrrolate excretion (Ae)		over 72 h after single administration
Secondary	Urine formoterol excretion (Ae)		Over 24 h after single administration
Secondary	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)
Secondary	Vital signs	systolic and diastolic blood pressure	over 24 h after single administration
Secondary	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

External Links

•   CSR Synopsis available in the Chiesi Clinical Study Register