HealthyPhase 1Gly1NCT01176851
Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers
A Phase 1 study testing Glycopyrrolate in people with Healthy, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the pharmacokinetics, the absolute bioavailability and the lung bioavailability of inhaled Glyco pMDI. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Glycopyrrolate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females healthy volunteers aged 18-65 years;
- Written informed consent obtained before the first trial related activity.
- Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
- Body Mass Index (BMI) between 18.0 and 32.0 kg/m2;
- Non- or ex-smokers who smoked < 5 pack years;
- Good physical and mental status;
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- Normal blood pressure and heart rate;
- Electrocardiogram (ECG)considered as normal;
- Results of laboratory tests within the normal ranges.
- Lung function measurements within the normal ranges.
Who cannot join
- Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication;
- 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.
- Positive HIV1 or HIV2 serology;
- Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C;
- Unsuitable veins for repeated venipuncture;
- History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening;
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- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
- Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol;
- 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;
- History of hypersensitivity to M3 Antagonists or any of the excipients contained in any of the formulations used in the trial;
- 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).
- Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole).
- 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.
- Heavy caffeine drinker.
Trial locations and contacts
1 site in 1 country.
About this study
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.
The purpose of this study is to investigate the pharmacokinetics, the absolute bioavailability and the lung bioavailability of inhaled Glyco pMDI.
- Conditions
- Healthy
- Being tested
- Glycopyrrolate
- Keywords
- None (study in healthy volunteers)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycopyrrolateDrug
Also called CHF 5259
Single administration of Glyco pMDI 100 µg
GlycopyrrolateDrug
Also called CHF 5259
Single administration of Glyco pMDI 100 µg after charcoal ingestion
GlycopyrrolateDrug
Also called Robinul Injection
Single intravenous injection of glycopyrrolate 100 µg
| Study group | Role | What they receive |
|---|---|---|
| Glyco pMDI | Experimental | Glyco pMDI 100 µg Receives: Drug: Glycopyrrolate |
| Glyco pMDI Charcoal | Experimental | Glyco pMDI 100 µg + charcoal block Receives: Drug: Glycopyrrolate |
| Glyco IV injection | Active comparator | Glyco solution for injection 100 µg Receives: Drug: Glycopyrrolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma and urine pharmacokinetics of glycopyrrolate
Measured: over 24 h post dose
Secondary outcomes (4)
Lung function parameters
Measured: over 24 h post dose
Cardiovascular parameters
Measured: over 24 h post dose
Clinical chemistry and haematology, urinalysis
Measured: over 24 h post dose
Adverse Events
Measured: during the whole study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dave Singh, MD, Principal investigator, Medicines Evaluation Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176851
- Sponsor's protocol ID
- CCD-0915-PR-0031
- Acronym
- Gly1
- Status last verified
- Oct 2021
- First submitted
- 5 Aug 2010
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01176851
- Acronym / sponsor ID
- Gly1 / CCD-0915-PR-0031
- Conditions
- Healthy
- Keywords
- None (study in healthy volunteers)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the pharmacokinetics, the absolute bioavailability and the lung bioavailability of inhaled Glyco pMDI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glyco pMDI | Experimental | Drug: GlycopyrrolateGlyco pMDI 100 µg |
| Glyco pMDI Charcoal | Experimental | Drug: GlycopyrrolateGlyco pMDI 100 µg + charcoal block |
| Glyco IV injection | Active comparator | Drug: GlycopyrrolateGlyco solution for injection 100 µg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females healthy volunteers aged 18-65 years;
- Written informed consent obtained before the first trial related activity.
- Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
- Body Mass Index (BMI) between 18.0 and 32.0 kg/m2;
- Non- or ex-smokers who smoked < 5 pack years;
Key exclusion criteria (14 listed)
- Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication;
- 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.
- Positive HIV1 or HIV2 serology;
- Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C;
- Unsuitable veins for repeated venipuncture;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlycopyrrolateAlso: CHF 5259Single administration of Glyco pMDI 100 µg | Drug | Glyco pMDI |
| GlycopyrrolateAlso: CHF 5259Single administration of Glyco pMDI 100 µg after charcoal ingestion | Drug | Glyco pMDI Charcoal |
| GlycopyrrolateAlso: Robinul InjectionSingle intravenous injection of glycopyrrolate 100 µg | Drug | Glyco IV injection |
Primary outcome
Plasma and urine pharmacokinetics of glycopyrrolate
Time frame: over 24 h post dose
4 secondary outcomes
Lung function parameters
Time frame: over 24 h post dose
Cardiovascular parameters
Time frame: over 24 h post dose
Clinical chemistry and haematology, urinalysis
Time frame: over 24 h post dose
Adverse Events
Time frame: during the whole study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dave Singh, MD principal investigator
Medicines Evaluation Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glycopyrrolate in people with Healthy, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma and urine pharmacokinetics of glycopyrrolate (time frame: over 24 h post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.