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Trial record 24 of 186 for:    GLYCOPYRROLATE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02040597
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Tracking Information
First Submitted Date  ICMJE January 9, 2014
First Posted Date  ICMJE January 20, 2014
Last Update Posted Date July 31, 2015
Study Start Date  ICMJE January 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2014)
Glycopyrrolate area under the curve (AUC) [ Time Frame: over 72 h after single administration ]
AUC until the last quantifiable concentration (AUCt)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02040597 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2014)
  • Glycopyrrolate other Pharmacokinetic parameters in plasma [ Time Frame: Over 72 h after single administration ]
    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 [ Time Frame: over 24 h after single administration ]
    AUCt, AUC until 24 h post dose (AUC0-24h), AUCinf, Cmax, tmax, half-life, clearance
  • BDP pharmacokinetic parameters in plasma [ Time Frame: over 24 h after single administration ]
    AUCt, AUCinf, Cmax, tmax, half-life
  • 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 [ Time Frame: A period of 3 to 7 weeks (from screening visit to follow-up phone call) ]
    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 [ Time Frame: over 24 h after single administration ]
    systolic and diastolic blood pressure
  • Electrocardiogram (ECG) parameters [ Time Frame: over 24 h after single administration ]
    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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE Drug: Beclometasone/Formoterol/Glycopyrrolate
Other Name: CHF 5993 pMDI
Study Arms  ICMJE Experimental: CHF5993 pMDI
CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/25 mcg) 4 inhalations
Intervention: Drug: Beclometasone/Formoterol/Glycopyrrolate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2015)
42
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2014)
48
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02040597
Other Study ID Numbers  ICMJE CCD-05993AA1-10
2013-002140-91 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chiesi Farmaceutici S.p.A.
Study Sponsor  ICMJE Chiesi Farmaceutici S.p.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Piotr Kuna, MD Medical University in Lodz
Principal Investigator: Kasia Jarus-Dziedzic, MD Biovirtus
PRS Account Chiesi Farmaceutici S.p.A.
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP