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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUN-101 via eFlow nebulizer | Experimental | 50 mcg glycopyrrolate via Electronic Nebulizer |
|
| SUN-101 via eFlow nebulizer with activated charcoal | Experimental | 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal |
|
| Seebri® Breezhaler® | Active Comparator | 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI |
|
| Seebri® Breezhaler® with activated charcoal | Active Comparator | : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
|
| : Glycopyrrolate Injection | Active Comparator | 50 mcg glycopyrrolate via IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUN-101 via eFlow nebulizer | Drug | 50 mcg glycopyrrolate via Electronic Nebulizer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | maximum observed concentration-Cmax is calculated from plasma concentrations analyzed from blood samples collected between 0 and 48 hr. | 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 | 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. | Up to Week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Week 5 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Head of Global Clinical, Respiratory and Bio-threapeutics | Sunovion Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Anne Street Medical Center | London | W1G 8HU | United Kingdom | |||
| Medicines evaluation Unit Ltd. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31253162 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group One | Participants received Seebri Breezhaler with activated charcoal 63 mcg; SUN-101 50 mcg via eFlow nebulizer with activated charcoal; Glycopyrrolate injection via IV infusion; SUN-101 50 mcg via e flow nebulizer; Seebri Breezhaler 63 mcg for each of the five treatment periods |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| SUN-101 via eFlow nebulizer with activated charcoal | Drug | 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal |
|
|
| Seebri® Breezhaler® | Drug | 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI |
|
|
| Seebri® Breezhaler® with activated charcoal | Drug | 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
|
|
| Glycopyrrolate Injection | Drug | 50 mcg glycopyrrolate via IV |
|
|
| 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. |
| 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to Week 5 |
| Manchester |
| M23 9QZ |
| United Kingdom |
| Treatment Group Two |
Participants received SUN-101 50 mcg via eFlow nebulizer, SUN-101 50 mcg via eFlow nebulier with activated charcoal; Seebri Breezhaler 63 mcg, Seebri Breezhaler 63 mcg with activated charcoal; Glycopyrrolate injection via IV infusion for each of the five treatment periods |
| FG002 | Treatment Group Three | Participants recveived SUN-101 50 mcg via eFlow nebulizer; Seebri Breezhaler 63mcg; SUN-101 50mcg via eFlow nebulizer with activated charcoal; Glycopyrrolate injection via IV infusion; Seebri Breezerhaler 63mcg with activated charcoal for each of the five treatment periods |
| FG003 | Treatment Group Four | Participants received Glycopyrrolate injection via IV infusion; Seebri Breezhaler 63mcg with activated charcoal; Seebri Breezhaler 63mcg; SUN-101 50 mcg via eFlow nebulizer with activated charcoal; SUN-101 50 mcg via eFlow nebulizer for each of the five treatment periods |
| FG004 | Treatment Group Five | Participants received Seebri Breezhaler 63mcg ; Glycopyrrolate injection via IV infusion; SUN-101 50 mcg via eFlow nebulizer; Seebri Breezhaler 63mcg with activated charcoal; SUN-101 50 mcg via eFlow nebulizer with activated charcoal; for each of the five treatment periods |
| FG005 | Treatment Group Six | Participants received Seebri Breezhaler 63mcg with activated charcoal ; Glycopyrrolate injection via IV infusion; SUN-101 50 mcg via eFlow nebulizer with activated charcoal; Seebri Breezhaler 63mcg SUN-101 50 mcg via eFlow nebulizer for each of the five treatment periods |
| FG006 | Treatment Group Seven | Participants received Seebri Breezhaler 63mcg ; SUN-101 50 mcg via eFlow nebulizer; Glycopyrrolate injection via IV infusion; SUN-101 50 mcg via eFlow nebulizer with activated charcoal; Seebri Breezhaler 63mcg with activated charcoal for each of the five treatment periods |
| FG007 | Treatment Group Eight | Participants received SUN-101 50 mcg via eFlow nebulizer with activated charcoal; SUN-101 50 mcg via eFlow nebulizer; Seebri Breezhaler 63mcg with activated charcoal; Seebri Breezhaler 63 mcg; Glycopyrrolate injection via IV infusion for each of the five treatment periods |
| FG008 | Treatment Group Nine | Participants received Glycopyrrolate injection via IV infusion; Seebri Breezhaler 63 mcg; Seebri Breezhaler 63mcg with activated charcoal; SUN-101 50 mcg via eFlow nebulizer SUN-101 50 mcg via eFlow nebulizer with activated charcoalfor each of the five treatment periods |
| FG009 | Treatment Group Ten | Participants received SUN-101 50 mcg via eFlow nebulizer with activated charcoal; Seebri Breezhaler 63mcg with activated charcoal; SUN-101 50 mcg via eFlow nebulizer; Glycopyrrolate injection via IV infusion;Seebri Breezhaler 63mcg for each of the five treatment periods |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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| Period 5 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total | Total number of participants from all treatment groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax | maximum observed concentration-Cmax is calculated from plasma concentrations analyzed from blood samples collected between 0 and 48 hr. | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication and have any evaluable PK data | Posted | Geometric Mean | Geometric Coefficient of Variation | Pg/mL | Up to Week 5 |
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| Primary | 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 | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication and have any evaluable PK data | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*pg/mL | Up to Week 5 |
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| Primary | 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. | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*pg/mL | Up to Week 5 |
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| Secondary | 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. | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters/hr | Up to Week 5 |
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| Secondary | 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. | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Up to Week 5 |
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| Secondary | 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. | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data. | Posted | Median | Full Range | hr | Up to Week 5 |
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| Secondary | 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. | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | Up to Week 5 |
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| Secondary | 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. | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*pg/mL | Up to Week 5 |
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| Secondary | 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. | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | up to week 5 |
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| Secondary | 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 | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters | up to week 5 |
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| Secondary | 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. | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data. | Posted | Median | Full Range | hr | up to week 5 |
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| Secondary | 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. | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | up to week 5 |
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| Secondary | 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. | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Pg/mL | up to week 5 |
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| Secondary | 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. | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*pg/mL | up to week 5 |
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| Secondary | 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. | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*pg/mL | up to week 5 |
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| Secondary | 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. | The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*pg/mL | up to week 5 |
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| Secondary | 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. | Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. | Posted | Number | participants | Up to Week 5 |
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| Secondary | 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. | Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. | Posted | Number | percentage of participants | Up to Week 5 |
|
up to week 5
A serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SUN-101 Via eFlow Nebulizer | 50 mcg glycopyrrolate via Electronic Nebulizer SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer | 0 | 29 | 1 | 29 | ||
| EG001 | SUN-101 Via eFlow Nebulizer With Activated Charcoal | 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal SUN-101 via eFlow nebulizer with activated charcoal: 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal | 0 | 29 | 3 | 29 | ||
| EG002 | Seebri® Breezhaler® | 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI | 0 | 28 | 3 | 28 | ||
| EG003 | Seebri® Breezhaler® With Activated Charcoal | : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal | 0 | 27 | 5 | 27 | ||
| EG004 | : Glycopyrrolate Injection | 50 mcg glycopyrrolate via IV infusion Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV | 0 | 27 | 4 | 27 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Respiratory Medical Director | Sunovion Pharmaceuticals Inc. | 1-866-503-6351 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Seebri® Breezhaler® With Activated Charcoal |
: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
| OG004 | : Glycopyrrolate Injection | 50 mcg glycopyrrolate via IV infusion Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV |
|
|
| OG003 | Seebri® Breezhaler® With Activated Charcoal | : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
| OG004 | : Glycopyrrolate Injection | 50 mcg glycopyrrolate via IV infusion Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV |
|
|
|
|
|
|
| OG003 | Seebri® Breezhaler® With Activated Charcoal | : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
|
|
| OG003 | Seebri® Breezhaler® With Activated Charcoal | : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
|
|
| OG003 | Seebri® Breezhaler® With Activated Charcoal | : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
|
|
: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
|
|
| OG003 |
| Seebri® Breezhaler® With Activated Charcoal |
: : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
|
|
| OG003 | Seebri® Breezhaler® With Activated Charcoal | : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
|
|
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI |
| OG003 | Seebri® Breezhaler® With Activated Charcoal | : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
|
|
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI |
| OG003 | Seebri® Breezhaler® With Activated Charcoal | : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
|
|
| OG002 | Seebri® Breezhaler® | 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI |
| OG003 | Seebri® Breezhaler® With Activated Charcoal | : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
|
|
| OG003 | Seebri® Breezhaler® With Activated Charcoal | : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
| OG004 | : Glycopyrrolate Injection | 50 mcg glycopyrrolate via IV infusion Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV |
|
|
| OG003 | Seebri® Breezhaler® With Activated Charcoal | : : 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal Seebri® Breezhaler® with activated charcoal: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal |
| OG004 | : Glycopyrrolate Injection | 50 mcg glycopyrrolate via IV infusion Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV |
|
|