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

This study has been completed.
Sponsor:
Information provided by:
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01176851
First received: August 5, 2010
Last updated: October 26, 2010
Last verified: October 2010
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Glycopyrrolate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Plasma and urine pharmacokinetics of glycopyrrolate [ Time Frame: over 24 h post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lung function parameters [ Time Frame: over 24 h post dose ] [ Designated as safety issue: Yes ]
  • Cardiovascular parameters [ Time Frame: over 24 h post dose ] [ Designated as safety issue: Yes ]
  • Clinical chemistry and haematology, urinalysis [ Time Frame: over 24 h post dose ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: during the whole study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: July 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glyco pMDI
Glyco pMDI 100 µg
Drug: Glycopyrrolate
Single administration of Glyco pMDI 100 µg
Other Name: CHF 5259
Experimental: Glyco pMDI Charcoal
Glyco pMDI 100 µg + charcoal block
Drug: Glycopyrrolate
Single administration of Glyco pMDI 100 µg after charcoal ingestion
Other Name: CHF 5259
Active Comparator: Glyco IV injection
Glyco solution for injection 100 µg
Drug: Glycopyrrolate
Single intravenous injection of glycopyrrolate 100 µg
Other Name: Robinul Injection

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176851

Locations
United Kingdom
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Dave Singh, MD Medicines Evaluation Unit
  More Information

No publications provided

Responsible Party: Martine Cartier, Head of Clinical Operations, Chiesi Farmaceutici SpA
ClinicalTrials.gov Identifier: NCT01176851     History of Changes
Other Study ID Numbers: CCD-0915-PR-0031
Study First Received: August 5, 2010
Last Updated: October 26, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Chiesi Farmaceutici S.p.A.:
None (study in healthy volunteers)

Additional relevant MeSH terms:
Charcoal
Glycopyrrolate
Antidotes
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014