Clinical trial NCT01176851: Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: None (study in healthy volunteers)
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2010-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Plasma and urine pharmacokinetics of glycopyrrolate
timeFrame: over 24 h post dose
Secondary outcomes:
measure: Lung function parameters
timeFrame: over 24 h post dose
measure: Cardiovascular parameters
timeFrame: over 24 h post dose
measure: Clinical chemistry and haematology, urinalysis
timeFrame: over 24 h post dose
measure: Adverse Events
timeFrame: during the whole study period
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit
Study officials:
affiliation: Medicines Evaluation Unit
name: Dave Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: