Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and the Lung Availability of … (NCT02743013) | Clinical Trial Compass
CompletedPhase 1
Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and the Lung Availability of CHF 5993 in Healthy Volunteers
Belgium50 participantsStarted 2016-04
Plain-language summary
This clinical pharmacology study is performed to evaluate the total systemic exposure and the lung availability of CHF 5993 DPI and pMDI with and without valved holding chamber, in healthy volunteers.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Subject's written informed consent obtained prior to any study related procedure.
✓. Ability to understand the study procedures, the risks involved, and ability to be trained to use the pMDI device correctly with AIM™ (Aerosol Inhalation Monitor) Vitalograph®.
✓. Ability to generate sufficient PIF (at least 40 L/min) using the In-Check device simulating NEXThaler® device.
✓. Male and female Caucasian subjects aged 18 to 55 years inclusive.
✓. Body mass index (BMI) within the range of 18 to 30 kg/m2 inclusive.
✓. Non-smokers or ex-smokers who smoked \< 5 pack years (pack-years = the number of cigarette packs per day, times the number of years) and stopped smoking \> 1 year prior to screening.
✓. Good physical and mental status, determined on the basis of the medical history and a general clinical examination, at screening and before randomization.
✓. Lung function measurements within normal limits (Normal values: FEV1/FVC is \> 0.70 and FEV1 \> 80% predicted).
Exclusion criteria
✕. Blood donation (equal or more than 450 ml) or blood loss, less than 8 weeks prior screening or prior randomization.
✕. Abnormal haemoglobin level defined as \< 10.5 g/dl
✕. For females only: pregnant and lactating female subjects, confirmed by a positive serum test at screening and/or urine test before randomization.
What they're measuring
1
Evaluation of the area under the curve (AUC0-t) for the systemic exposure of B17MP (active metabolite of Beclometasone Dipropionate), Formoterol and Glycopirronium Bromide.
Timeframe: 72 hours after adminstration
2
Evaluation of the Area under the curve (AUC) for the lung exposure of B17MP (active metabolite of Beclometasone Dipropionate), Formoterol and Glycopirronium Bromide after charcoal blockage.
Timeframe: 72 hours after adminstration
3
Evaluation of the Maximum Plasma Concentration (Cmax) for the systemic exposure of B17MP (active metabolite of Beclometasone Dipropionate), Formoterol and Glycopirronium Bromide.
Timeframe: 72 hours after adminstration
4
Evaluation of the Maximum Plasma Concentration (Cmax) for the lung exposure of B17MP (active metabolite of Beclometasone Dipropionate), Formoterol and Glycopirronium Bromide after charcoal blockage.
✕. Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C.
✕. Unsuitable veins for repeated venipuncture.
✕. Documented history of alcohol abuse within 12 months prior to screening.
✕. Documented history of drug abuse within 12 months prior to screening, or positive urine drug test performed at screening and/or before randomization.