A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: Beclometasone/Formoterol/Glycopyrrolate
- Registration Number
- NCT02040597
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Healthy volunteers and
- Subjects with mild, moderate and severe renal impairment
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CHF5993 pMDI Beclometasone/Formoterol/Glycopyrrolate CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/25 mcg) 4 inhalations
- Primary Outcome Measures
Name Time Method Glycopyrrolate area under the curve (AUC) over 72 h after single administration AUC until the last quantifiable concentration (AUCt)
- Secondary Outcome Measures
Name Time Method Urine formoterol excretion (Ae) Over 24 h after single administration Glycopyrrolate other Pharmacokinetic parameters in plasma 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 over 24 h after single administration AUCt, AUC until 24 h post dose (AUC0-24h), AUCinf, Cmax, tmax, half-life, clearance
Vital signs over 24 h after single administration systolic and diastolic blood pressure
Electrocardiogram (ECG) parameters 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)
BDP pharmacokinetic parameters in plasma over 24 h after single administration AUCt, AUCinf, Cmax, tmax, half-life
Adverse events 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
Urine Glycopyrrolate excretion (Ae) over 72 h after single administration
Trial Locations
- Locations (2)
Medical University in Lodz
🇵🇱Lodz, Ul. Kopcińskiego 22, Poland
Biovirtus Research Site
🇵🇱Nadarzyn, Mokra 7, Poland