Chronic Obstructive Pulmonary Disease (COPD)
Conditions
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.
Interventions
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycopyrrolate area under the curve (AUC) | over 72 h after single administration | AUC until the last quantifiable concentration (AUCt) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| BDP pharmacokinetic parameters in plasma | over 24 h after single administration | AUCt, AUCinf, Cmax, tmax, half-life |
| Urine Glycopyrrolate excretion (Ae) | over 72 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 |
| 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 |
| 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) |
| Urine formoterol excretion (Ae) | Over 24 h after single administration | — |
Countries
Poland
Outcome results
None listed