COPDPhase 1GOLDEN7NCT02512302
Study to Determine the Amount of Glycopyrrolate Absorbed in the Lungs After Taking the Medicine With a eFlow Nebulizer and Seebri® Breezhaler® With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).
A Phase 1 study testing SUN-101 via eFlow nebulizer, SUN-101 via eFlow nebulizer with activated charcoal and Seebri® Breezhaler® in people with COPD, run by Sunovion Respiratory Development Inc. at 2 sites in United Kingdom.
Trial summary
The purpose of this research study is to determine the amount of medicine absorbed in the lungs following dosing via eFlow nebulizer and Seebri® Breezhaler® with and without activated charcoal in subjects with moderate to severe chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- COPD
- What is being tested?
- SUN-101 via eFlow nebulizer, SUN-101 via eFlow nebulizer with activated charcoal and Seebri® Breezhaler®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2015to Apr 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 40 to 70 years-old, inclusive.
- A clinical diagnosis of moderate to severe COPD according to the GOLD 2014 guidelines.
- Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
- Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 ≥ 30% and ≤ 80% of predicted normal during the Screening Period.
- Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio ≤ 0.70 during the Screening Period.
- Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and/or European Respiratory Society (ERS) guidelines (2005).
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- Subject, if female ≤ 70 years of age and of child bearing potential, must have a negative urine pregnancy test at Visit 1. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control: a) an oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following participation; b) barrier method of contraception, eg, condom and /or diaphragm with spermicide while participating in the study; and/or c) abstinence.
- Willing and able to remain at the study site for at least 24 hours for each treatment day.
- Willing and able to provide written informed consent.
- Willing and able to attend all study visits and adhere to all study assessments and procedures.
Who cannot join
- Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject, included but not limited to the following:
- Unstable ischemic heart disease (diagnosis of myocardial infarction or admission for acute coronary syndrome) within 6 months of screening.
- Unstable cardiac arrhythmia or heart failure (change in treatment plan) within 6 months.
- Treatment for diabetes mellitus within 6 months of screening.
- Current evidence or history of a clinically significant abnormality of cardiac rhythm and/or conduction findings.
- Concomitant clinically significant respiratory disease other than COPD (eg, asthma, tuberculosis, bronchiectasis, or other non-specific pulmonary disease).
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- History of malignancy of any organ system treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin.
- Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to the Screening Period.
- Use of daily oxygen therapy > 10 hours per day.
- Use of oral, intravenous, or intramuscular steroids within 3 months prior to the Screening Period.
- Respiratory tract infection within 6 weeks prior to or during the Screening Period.
- Significant blood loss (> 500 mL) or donated blood within 60 days preceding screening or plans to donate blood within 60 days after completing the study.
- History of or clinically significant ongoing bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within the previous 6 months.
- History of narrow-angle glaucoma.
- Prolonged QTc interval (> 450 msec for males and > 470 msec for females) during the Screening Period, or history of long QT syndrome.
- Recent documented history (previous 12 months) of substance abuse.
- .Positive urine drug screen at Visit 1 provided the subject is unable to produce a valid medical rationale for the test result (eg, prescription medication).
- Positive HbsAg, Hepatitis C antibody, or HIV 1/2 antibody test at Screening.
- History of hypersensitivity or intolerance to aerosol medications, β2-agonists, anticholinergics, or sympathomimetic amines.
- Significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator.
- Participation in another investigational drug study where drug was received within 30 days prior to the Screening Period, or current participation in another investigational drug trial in which study treatment is being administered, including a SUN-101 study
- Previously received SUN-101 (active treatment; formerly known as EP-101).
- Previously received any glycopyrrolate product within 28 days of Screening.
- Subject is taking theophylline.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Queen Anne Street Medical Center
London, W1G 8HU
Medicines evaluation Unit Ltd.
Manchester, M23 9QZ
About this study
Official title: A Crossover Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and Lung Bioavailability of SUN-101 and Seebri® Breezhaler® Administered With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this research study is to determine the amount of medicine absorbed in the lungs following dosing via eFlow nebulizer and Seebri® Breezhaler® with and without activated charcoal in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).
Read the detailed description
This is a randomized, open-label, single-dose per dosing period, five-way crossover study in subjects 40 to 70 years of age with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines. After a subject provides consent for study participation, there will be a Screening Period lasting up to 3 weeks to determine study eligibility and to allow for appropriate washout of prohibited medications.
Eligible subjects will be randomized to one of 10 treatment Sequences. There will be a minimum of a 7-day washout period between each treatment visit. At each visit, subjects will receive one dose of study medication according to the sequence assigned.
Subjects with a ≥ 20% decrease in forced expiratory volume in one second (FEV1) based on review of the Visit predose value compared with the Screening value will be evaluated by the investigator for continuation in the study.
Subjects taking theophylline will not be able to participate in the study.
- Conditions
- COPD
- Being tested
- SUN-101 via eFlow nebulizer, SUN-101 via eFlow nebulizer with activated charcoal, Seebri® Breezhaler®, Seebri® Breezhaler® with activated charcoal, Glycopyrrolate Injection
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUN-101 via eFlow nebulizerDrug
Also called Glycopyrrolate
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer with activated charcoalDrug
Also called Glycopyrrolate
50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal
Seebri® Breezhaler®Drug
Also called glycopyrronium, glycopyrronium bromide
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler® with activated charcoalDrug
Also called glycopyrronium, glycopyrronium bromide
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal
Glycopyrrolate InjectionDrug
Also called Glycopyrrolate
50 mcg glycopyrrolate via IV
| Study group | Role | What they receive |
|---|---|---|
| SUN-101 via eFlow nebulizer | Experimental | 50 mcg glycopyrrolate via Electronic Nebulizer Receives: Drug: SUN-101 via eFlow nebulizer |
| SUN-101 via eFlow nebulizer with activated charcoal | Experimental | 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal Receives: Drug: SUN-101 via eFlow nebulizer with activated charcoal |
| Seebri® Breezhaler® | Active comparator | 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI Receives: Drug: Seebri® Breezhaler® |
| Seebri® Breezhaler® with activated charcoal | Active comparator | : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Receives: Drug: Seebri® Breezhaler® with activated charcoal |
| : Glycopyrrolate Injection | Active comparator | 50 mcg glycopyrrolate via IV infusion Receives: Drug: Glycopyrrolate Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
maximum observed concentration-Cmax is calculated from plasma concentrations analyzed from blood samples collected between 0 and 48 hr.
Measured: Up to Week 5
Area Under the Curve From Time Zero to 24 Hours (AUC0_24)
Area under the drug concentration-time curve from time zero to 24 hours postdose pk parameteres are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr
Measured: Up to Week 5
Area Under the Curve From Time Zero to Infinity (AUC0_infinity)
calculated by summing AUC0-last and the AUC extrapolated from tlast to infinity: AUC0-∞ = AUC0-last+ Clast / | λz | Clast / | λz | is the extrapolated area under the curve from tlast to infinity. If this quantity is greater than 20% of AUC0-∞, then AUC0-∞ was considered to be missing.
Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Measured: Up to Week 5
Secondary outcomes (15)
Clearance (CL) for IV Infusion of 50 mcg of Glycopyrrolate
calculated as Dose/AUC0-inf after the IV dose administration. If AUC0-inf is missing, then CL was considered as missing.
Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Measured: Up to Week 5
Volume of Distribution During the Elimination Phase (Vz) for IV Infusion of 50 mcg of Glycopyrrolate
calculated as Dose/(AUC0-inf*λz). Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Measured: Up to Week 5
Time of Occurrence of Cmax (Tmax) for IV Infusion of 50 mcg of Glycopyrrolate
The time 0 is based on start of the infusion. Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Measured: Up to Week 5
Terminal Half Life (t1/2) for IV Infusion of 50 mcg of Glycopyrrolate
calculated as ln(2) / λz . At least 3 data points at the terminal elimination phase were required to determine t½.
Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Measured: Up to Week 5
Area Under the Curve Zero to 48 Hours (AUC0_48) for Seebri Breezhaler and Sun-101 AUC0-48, CL/F, Vz/F, Tmax, t½, and Dose Normalized Cmax, AUC0-24, AUC0-48, AUC0-∞ - AUC0-∞ -
Area under the drug concentration-time curve from time zero to 48 hours postdose Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Measured: Up to Week 5
Apparent Clearance Calculated as Dose/AUC0-INF After Extravascular Dose Administration of Seebri Breezhaler and SUN-101
calculated as Dose/AUC0-∞ after extravascular dose administration, where F = Bioavailability. If AUC0-∞ is missing, then CL/F is considered as missing.
Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Measured: up to week 5
Apparent Volume of Distribution (Vz/F) After Extravascular Dose Administration of Seebri Breezhaler and SUN-101
calculated as Dose/(AUC0-∞* λz), where F = Bioavailability. If AUC0-∞ is missing, then Vz/F is considered as missing.
Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr
Measured: up to week 5
Time of Occurrence of Cmax (Tmax) for Seebri Breezhaler and SUN-101
The time 0 is based on start of the inhalation. Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Measured: up to week 5
Terminal Half Life (t1/2) for for Seebri Breezhaler and SUN-101
calculated as ln(2) / λz . At least 3 data points at the terminal elimination phase were required to determine t½.
Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Measured: up to week 5
Dose Normalized Cmax for Seebri and SUN-101.
Maximum observed concentration multiplied by the dose normalization factor. Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
The dose normalization factor calculation has two components: dose equivalent glycopyrrolate amount and the delivery efficiency (% dose delivered). For Sun-101 50 mcg, the dose normalization factor is 1.59, for Seebri Breezhaler it is 0.9.
Measured: up to week 5
Dose Normalized Area Under the Curve Zero to 24 Hours (AUC0_24) for Seebri and SUN-101
Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Area under the drug concentration-time curve from time zero to 24 hours postdose multiplied by the dose normalization factor. The dose normalization factor calculation has two components: dose equivalent glycopyrrolate amount and the delivery efficiency (% dose delivered). For Sun-101 50 mcg, the dose normalization factor is 1.59, for Seebri Breezhaler it is 0.9.
Measured: up to week 5
Dose Normalized Area Under the Curve Zero to 48 Hours (AUC0_48) for Seebri and SUN-101
Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Area under the drug concentration-time curve from time zero to 48 hours postdose multiplied by the dose normalization factor. The dose normalization factor calculation has two components: dose equivalent glycopyrrolate amount and the delivery efficiency (% dose delivered). For Sun-101 50 mcg, the dose normalization factor is 1.59, for Seebri Breezhaler it is 0.9.
Measured: up to week 5
Dose Normalized Area Under the Curve Zero From Zero to Infinity (AUC0_inf) for Seebri and SUN-101
Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Area under the drug concentration-time curve from zero to infinity, calculated by summing AUC0-last and the AUC extrapolated from tlast to infinity multiplied by the dose normalization factor: dose normalization factor* (AUC0-∞ = AUC0-last+ Clast / | λz | ) Clast / | λz | is the extrapolated area under the curve from tlast to infinity. If this quantity is greater than 20% of AUC0-∞, then AUC0-∞ was considered to be missing.
The dose normalization factor calculation has two components: dose equivalent glycopyrrolate amount and the delivery efficiency (% dose delivered). For Sun-101 50mcg , the dose normalization factor is 1.59, for Seebri Breezhaler it is 0.9.
Measured: up to week 5
The Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
An adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
Measured: Up to Week 5
The Percentage of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
An adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.
Measured: Up to Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunovion Respiratory Development Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Head of Global Clinical, Respiratory and Bio-threapeutics, Study chair, Sunovion Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512302
- Sponsor's protocol ID
- SUN101-105
- Acronym
- GOLDEN7
- Status last verified
- Sep 2018
- First submitted
- 24 Jul 2015
- Last updated
- 25 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Leaker BR, Singh D, Nicholson GC, Hezelova B, Goodin T, Ozol-Godfrey A, Galluppi G, Barnes PJ. Evaluation of systemic absorption and bronchodilator effect of glycopyrronium bromide delivered by nebulizer or a dry powder inhaler in subjects with chronic obstructive pulmonary disease. Respir Res. 2019 Jun 28;20(1):132. doi: 10.1186/s12931-019-1113-z.
PubMed 31253162
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and Lung Bioavailability of SUN-101 and Seebri® Breezhaler® Administered With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02512302
- Acronym / sponsor ID
- GOLDEN7 / SUN101-105
- Conditions
- COPD
- Keywords
- COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sunovion Respiratory Development Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Posted 14 Sep 2018
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 research study is to determine the amount of medicine absorbed in the lungs following dosing via eFlow nebulizer and Seebri® Breezhaler® with and without activated charcoal in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).
Detailed description
This is a randomized, open-label, single-dose per dosing period, five-way crossover study in subjects 40 to 70 years of age with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines. After a subject provides consent for study participation, there will be a Screening Period lasting up to 3 weeks to determine study eligibility and to allow for appropriate washout of prohibited medications.
Eligible subjects will be randomized to one of 10 treatment Sequences. There will be a minimum of a 7-day washout period between each treatment visit. At each visit, subjects will receive one dose of study medication according to the sequence assigned.
Subjects with a ≥ 20% decrease in forced expiratory volume in one second (FEV1) based on review of the Visit predose value compared with the Screening value will be evaluated by the investigator for continuation in the study.
Subjects taking theophylline will not be able to participate in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SUN-101 via eFlow nebulizer | Experimental | Drug: SUN-101 via eFlow nebulizer50 mcg glycopyrrolate via Electronic Nebulizer |
| SUN-101 via eFlow nebulizer with activated charcoal | Experimental | Drug: SUN-101 via eFlow nebulizer with activated charcoal50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal |
| Seebri® Breezhaler® | Active comparator | Drug: Seebri® Breezhaler®63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI |
| Seebri® Breezhaler® with activated charcoal | Active comparator | Drug: Seebri® Breezhaler® with activated charcoal: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
| : Glycopyrrolate Injection | Active comparator | Drug: Glycopyrrolate Injection50 mcg glycopyrrolate via IV infusion |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients 40 to 70 years-old, inclusive.
- A clinical diagnosis of moderate to severe COPD according to the GOLD 2014 guidelines.
- Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
- Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 ≥ 30% and ≤ 80% of predicted normal during the Screening Period.
- Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio ≤ 0.70 during the Screening Period.
Key exclusion criteria (24 listed)
- Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject, included but not limited to the following:
- Current evidence or history of a clinically significant abnormality of cardiac rhythm and/or conduction findings.
- Concomitant clinically significant respiratory disease other than COPD (eg, asthma, tuberculosis, bronchiectasis, or other non-specific pulmonary disease).
- History of malignancy of any organ system treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin.
- Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to the Screening Period.
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 |
|---|---|---|
| SUN-101 via eFlow nebulizerAlso: Glycopyrrolate50 mcg glycopyrrolate via Electronic Nebulizer | Drug | SUN-101 via eFlow nebulizer |
| SUN-101 via eFlow nebulizer with activated charcoalAlso: Glycopyrrolate50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal | Drug | SUN-101 via eFlow nebulizer with activated charcoal |
| Seebri® Breezhaler®Also: glycopyrronium, glycopyrronium bromide63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI | Drug | Seebri® Breezhaler® |
| Seebri® Breezhaler® with activated charcoalAlso: glycopyrronium, glycopyrronium bromide63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal | Drug | Seebri® Breezhaler® with activated charcoal |
| Glycopyrrolate InjectionAlso: Glycopyrrolate50 mcg glycopyrrolate via IV | Drug | : Glycopyrrolate Injection |
Primary outcome
Cmax
Time frame: Up to Week 5
maximum observed concentration-Cmax is calculated from plasma concentrations analyzed from blood samples collected between 0 and 48 hr.
Area Under the Curve From Time Zero to 24 Hours (AUC0_24)
Time frame: Up to Week 5
Area under the drug concentration-time curve from time zero to 24 hours postdose pk parameteres are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr
Area Under the Curve From Time Zero to Infinity (AUC0_infinity)
Time frame: Up to Week 5
calculated by summing AUC0-last and the AUC extrapolated from tlast to infinity: AUC0-∞ = AUC0-last+ Clast / | λz | Clast / | λz | is the extrapolated area under the curve from tlast to infinity. If this quantity is greater than 20% of AUC0-∞, then AUC0-∞ was considered to be missing. Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
15 secondary outcomes
Clearance (CL) for IV Infusion of 50 mcg of Glycopyrrolate
Time frame: Up to Week 5
Volume of Distribution During the Elimination Phase (Vz) for IV Infusion of 50 mcg of Glycopyrrolate
Time frame: Up to Week 5
Time of Occurrence of Cmax (Tmax) for IV Infusion of 50 mcg of Glycopyrrolate
Time frame: Up to Week 5
Terminal Half Life (t1/2) for IV Infusion of 50 mcg of Glycopyrrolate
Time frame: Up to Week 5
Area Under the Curve Zero to 48 Hours (AUC0_48) for Seebri Breezhaler and Sun-101 AUC0-48, CL/F, Vz/F, Tmax, t½, and Dose Normalized Cmax, AUC0-24, AUC0-48, AUC0-∞ - AUC0-∞ -
Time frame: Up to Week 5
Apparent Clearance Calculated as Dose/AUC0-INF After Extravascular Dose Administration of Seebri Breezhaler and SUN-101
Time frame: up to week 5
Apparent Volume of Distribution (Vz/F) After Extravascular Dose Administration of Seebri Breezhaler and SUN-101
Time frame: up to week 5
Time of Occurrence of Cmax (Tmax) for Seebri Breezhaler and SUN-101
Time frame: up to week 5
Terminal Half Life (t1/2) for for Seebri Breezhaler and SUN-101
Time frame: up to week 5
Dose Normalized Cmax for Seebri and SUN-101.
Time frame: up to week 5
Dose Normalized Area Under the Curve Zero to 24 Hours (AUC0_24) for Seebri and SUN-101
Time frame: up to week 5
Dose Normalized Area Under the Curve Zero to 48 Hours (AUC0_48) for Seebri and SUN-101
Time frame: up to week 5
Dose Normalized Area Under the Curve Zero From Zero to Infinity (AUC0_inf) for Seebri and SUN-101
Time frame: up to week 5
The Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Time frame: Up to Week 5
The Percentage of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Time frame: Up to Week 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31253162Leaker BR, Singh D, Nicholson GC, Hezelova B, Goodin T, Ozol-Godfrey A, Galluppi G, Barnes PJ. Evaluation of systemic absorption and bronchodilator effect of glycopyrronium bromide delivered by nebulizer or a dry powder inhaler in subjects with chronic obstructive pulmonary disease. Respir Res. 2019 Jun 28;20(1):132. doi: 10.1186/s12931-019-1113-z.
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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.
Head of Global Clinical, Respiratory and Bio-threapeutics study chair
Sunovion Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SUN-101 via eFlow nebulizer, SUN-101 via eFlow nebulizer with activated charcoal and Seebri® Breezhaler® in people with COPD, run by Sunovion Respiratory Development Inc. at 2 sites 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 24 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 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 14 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax (time frame: Up to Week 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02512302, which also lists 1 linked publication.
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 25 Oct 2018.