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.
2 other identifiers
interventional
42
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 9, 2014
CompletedFirst Posted
Study publicly available on registry
January 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedOctober 29, 2021
October 1, 2021
1.2 years
January 9, 2014
October 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Glycopyrrolate area under the curve (AUC)
AUC until the last quantifiable concentration (AUCt)
over 72 h after single administration
Secondary Outcomes (8)
Glycopyrrolate other Pharmacokinetic parameters in plasma
Over 72 h after single administration
B17MP and Formoterol pharmacokinetic parameters in plasma
over 24 h after single administration
BDP pharmacokinetic parameters in plasma
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
- +3 more secondary outcomes
Study Arms (1)
CHF5993 pMDI
EXPERIMENTALCHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/25 mcg) 4 inhalations
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers and
- Subjects with mild, moderate and severe renal impairment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Biovirtus Research Site
Nadarzyn, Mokra 7, 05-830, Poland
Medical University in Lodz
Lodz, Ul. Kopcińskiego 22, 90-153, Poland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Piotr Kuna, MD
Medical University in Lodz
- PRINCIPAL INVESTIGATOR
Kasia Jarus-Dziedzic, MD
Biovirtus
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2014
First Posted
January 20, 2014
Study Start
January 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
October 29, 2021
Record last verified: 2021-10