Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers (Gly1)

Chiesi

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Glycopyrrolate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01176851

CCD-0915-PR-0031

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males and females healthy volunteers aged 18-65 years;
2. Written informed consent obtained before the first trial related activity.
3. Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
4. Body Mass Index (BMI) between 18.0 and 32.0 kg/m2;
5. Non- or ex-smokers who smoked < 5 pack years;
6. Good physical and mental status;
7. Normal blood pressure and heart rate;
8. Electrocardiogram (ECG)considered as normal;
9. Results of laboratory tests within the normal ranges.
10. Lung function measurements within the normal ranges.

Exclusion criteria

1. Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication;
2. 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.
3. Positive HIV1 or HIV2 serology;
4. Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C;
5. Unsuitable veins for repeated venipuncture;
6. History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening;
7. Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
8. Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol;
9. 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;
10. History of hypersensitivity to M3 Antagonists or any of the excipients contained in any of the formulations used in the trial;
11. 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).
12. Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole).
13. 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.
14. Heavy caffeine drinker.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Glyco pMDI

Experimental group

Description:

Glyco pMDI 100 µg

Treatment:

Drug: Glycopyrrolate

Drug: Glycopyrrolate

Drug: Glycopyrrolate

Glyco pMDI Charcoal

Experimental group

Description:

Glyco pMDI 100 µg + charcoal block

Treatment:

Drug: Glycopyrrolate

Drug: Glycopyrrolate

Drug: Glycopyrrolate

Glyco IV injection

Active Comparator group

Description:

Glyco solution for injection 100 µg

Treatment:

Drug: Glycopyrrolate

Drug: Glycopyrrolate

Drug: Glycopyrrolate