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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
Beclometasone/Formoterol/Glycopyrrolate
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Biovirtus Research Site
  • Medical University in Lodz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CHF5993 pMDI

Arm Description

CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/25 mcg) 4 inhalations

Outcomes

Primary Outcome Measures

Glycopyrrolate area under the curve (AUC)
AUC until the last quantifiable concentration (AUCt)

Secondary Outcome Measures

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
B17MP and Formoterol pharmacokinetic parameters in plasma
AUCt, AUC until 24 h post dose (AUC0-24h), AUCinf, Cmax, tmax, half-life, clearance
BDP pharmacokinetic parameters in plasma
AUCt, AUCinf, Cmax, tmax, half-life
Urine Glycopyrrolate excretion (Ae)
Urine formoterol excretion (Ae)
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
Vital signs
systolic and diastolic blood pressure
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)

Full Information

First Posted
January 9, 2014
Last Updated
October 28, 2021
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02040597
Brief Title
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHF5993 pMDI
Arm Type
Experimental
Arm Description
CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/25 mcg) 4 inhalations
Intervention Type
Drug
Intervention Name(s)
Beclometasone/Formoterol/Glycopyrrolate
Other Intervention Name(s)
CHF 5993 pMDI
Primary Outcome Measure Information:
Title
Glycopyrrolate area under the curve (AUC)
Description
AUC until the last quantifiable concentration (AUCt)
Time Frame
over 72 h after single administration
Secondary Outcome Measure Information:
Title
Glycopyrrolate other Pharmacokinetic parameters in plasma
Description
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
Title
B17MP and Formoterol pharmacokinetic parameters in plasma
Description
AUCt, AUC until 24 h post dose (AUC0-24h), AUCinf, Cmax, tmax, half-life, clearance
Time Frame
over 24 h after single administration
Title
BDP pharmacokinetic parameters in plasma
Description
AUCt, AUCinf, Cmax, tmax, half-life
Time Frame
over 24 h after single administration
Title
Urine Glycopyrrolate excretion (Ae)
Time Frame
over 72 h after single administration
Title
Urine formoterol excretion (Ae)
Time Frame
Over 24 h after single administration
Title
Adverse events
Description
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)
Title
Vital signs
Description
systolic and diastolic blood pressure
Time Frame
over 24 h after single administration
Title
Electrocardiogram (ECG) parameters
Description
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)
Time Frame
over 24 h after single administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Kuna, MD
Organizational Affiliation
Medical University in Lodz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kasia Jarus-Dziedzic, MD
Organizational Affiliation
Biovirtus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biovirtus Research Site
City
Nadarzyn
State/Province
Mokra 7
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Medical University in Lodz
City
Lodz
State/Province
Ul. Kopcińskiego 22
ZIP/Postal Code
90-153
Country
Poland

12. IPD Sharing Statement

Links:
URL
https://www.chiesi.com/clinic/CSR_Synopsis_CCD-05993AA1-10.pdf
Description
CSR Synopsis available in the Chiesi Clinical Study Register

Learn more about this trial

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

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