Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to investigate the pharmacokinetics, the absolute bioavailability and the lung bioavailability of inhaled Glyco pMDI.

Official Title
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Pharmacokinetic, Randomized, Open-label, Single-dose, 3-way Cross-over Study of Intravenous and Inhaled Glycopyrrolate With or Without Charcoal Block Ingestion in Healthy Volunteers.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Glycopyrrolate
* Drug: Glycopyrrolate
* Drug: Glycopyrrolate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females healthy volunteers aged 18-65 years; Written informed consent obtained before the first trial related activity. Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly. Body Mass Index (BMI) between 18.0 and 32.0 kg/m2; Non- or ex-smokers who smoked < 5 pack years; Good physical and mental status; Normal blood pressure and heart rate; Electrocardiogram (ECG)considered as normal; Results of laboratory tests within the normal ranges. Lung function measurements within the normal ranges. Exclusion Criteria: Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication; Pregnant or lactating women or women of childbearing potential, UNLESS they are using one or more of the acceptable methods of contraception. Male subjects not willing to use an acceptable method of contraception. Positive HIV1 or HIV2 serology; Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C; Unsuitable veins for repeated venipuncture; History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening; Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation; Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol; Participation in another clinical trial less than 8 weeks prior to inhalation of the study medication; participation in another clinical trial using radioactive material within 1 calendar year; History of hypersensitivity to M3 Antagonists or any of the excipients contained in any of the formulations used in the trial; Any drug treatment, including prescribed or OTC medicines as well as vitamins, homeopathic remedies etc, taken in the 14 days (2 months for enzyme-inducing or enzyme-inhibiting drugs e.g., glucocorticoids, phenobarbital, isoniazid) preceding the first intake of the study drug, with the exception of occasional paracetamol (maximum 2 g per day with a maximum of 10 g per 14 days for mild non-excluding conditions). Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole). Subjects who refuse to abstain from alcohol or caffeine containing foods or beverages or grapefruit containing foods or beverages from 48 hour prior to the first intake of study medication and for the entire duration of the study. Heavy caffeine drinker.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glyco pMDI<br>Glyco pMDI 100 µg | Drug: Glycopyrrolate<br>* Single administration of Glyco pMDI 100 µg<br>* Other names: CHF 5259;|
| Experimental: Glyco pMDI Charcoal<br>Glyco pMDI 100 µg + charcoal block | Drug: Glycopyrrolate<br>* Single administration of Glyco pMDI 100 µg after charcoal ingestion<br>* Other names: CHF 5259;|
| Active Comparator: Glyco IV injection<br>Glyco solution for injection 100 µg | Drug: Glycopyrrolate<br>* Single intravenous injection of glycopyrrolate 100 µg<br>* Other names: Robinul Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma and urine pharmacokinetics of glycopyrrolate |  | over 24 h post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function parameters |  | over 24 h post dose | 
| Cardiovascular parameters |  | over 24 h post dose | 
| Clinical chemistry and haematology, urinalysis |  | over 24 h post dose | 
| Adverse Events |  | during the whole study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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None (study in healthy volunteers)