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

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.

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Glycopyrrolate; Drug: Glycopyrrolate; Drug: Glycopyrrolate

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M23 9QZ
    • Medicines Evaluation Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.

Publications and helpful links

Helpful Links

• CSR Synopsis available in the Chiesi Clinical Study Register

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: August 5, 2010
• First Submitted That Met QC Criteria: August 5, 2010
• First Posted (Estimate): August 6, 2010

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: None (study in healthy volunteers)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Glycopyrrolate
• Other Study ID Numbers: CCD-0915-PR-0031