A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment. (TRIPLE10)

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.

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 Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Beclometasone/Formoterol/Glycopyrrolate

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• Poland
  • Mokra 7
    • Nadarzyn, Mokra 7, Poland, 05-830
      • Biovirtus Research Site
  • Ul. Kopcińskiego 22
    • Lodz, Ul. Kopcińskiego 22, Poland, 90-153
      • Medical University in Lodz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHF5993 pMDI; CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/25 mcg) 4 inhalations	Drug: Beclometasone/Formoterol/Glycopyrrolate; Other Names: CHF 5993 pMDI

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Piotr Kuna, MD, Medical University in Lodz; Principal Investigator: Kasia Jarus-Dziedzic, MD, Biovirtus

Publications and helpful links

Helpful Links

• CSR Synopsis available in the Chiesi Clinical Study Register

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: January 9, 2014
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Beclomethasone; Glycopyrrolate; Formoterol Fumarate
• Other Study ID Numbers: CCD-05993AA1-10; 2013-002140-91 (EudraCT Number)