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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01176851
• Date of registration: 05/08/2010
• Primary sponsor: Chiesi Farmaceutici S.p.A.
• Public title: Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers Gly1
• Scientific title: 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.
• Date of first enrolment: July 2010
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01176851
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United Kingdom

Contacts

• Name: Dave Singh, MD
• Affiliation: Medicines Evaluation Unit

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Glycopyrrolate

Primary Outcome(s)

Plasma and urine pharmacokinetics of glycopyrrolate [Time Frame: over 24 h post dose]

Secondary Outcome(s)

Adverse Events [Time Frame: during the whole study period]

Cardiovascular parameters [Time Frame: over 24 h post dose]

Clinical chemistry and haematology, urinalysis [Time Frame: over 24 h post dose]

Lung function parameters [Time Frame: over 24 h post dose]

Secondary ID(s)

CCD-0915-PR-0031

Source(s) of Monetary Support

Please refer to primary and secondary sponsors