Trial Outcomes & Findings for 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). (NCT NCT02512302)
NCT ID: NCT02512302
Last Updated: 2018-10-25
Results Overview
maximum observed concentration-Cmax is calculated from plasma concentrations analyzed from blood samples collected between 0 and 48 hr.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Up to Week 5
Results posted on
2018-10-25
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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Period 1
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Period 1
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Period 2
STARTED
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Period 2
COMPLETED
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Period 3
STARTED
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Period 3
COMPLETED
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Period 3
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Period 4
STARTED
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Period 4
COMPLETED
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Period 4
NOT COMPLETED
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Period 5
STARTED
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Period 5
COMPLETED
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Period 5
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
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Period 1
Adverse Event
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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Period 2
Adverse Event
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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Period 3
Lost to Follow-up
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0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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Period 4
Adverse Event
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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Baseline Characteristics
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).
Baseline characteristics by cohort
| Measure |
Total
n=30 Participants
Total number of participants from all treatment groups
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication and have any evaluable PK data
maximum observed concentration-Cmax is calculated from plasma concentrations analyzed from blood samples collected between 0 and 48 hr.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=29 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
SUN-101 Via eFlow Nebulizer With Activated Charcoal
n=29 Participants
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
|
Seebri® Breezhaler®
n=28 Participants
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
Seebri® Breezhaler® With Activated Charcoal
n=26 Participants
: : 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
|
: Glycopyrrolate Injection
n=27 Participants
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Cmax
|
53.75 Pg/mL
Geometric Coefficient of Variation 51.746
|
49.27 Pg/mL
Geometric Coefficient of Variation 60.996
|
166.79 Pg/mL
Geometric Coefficient of Variation 76.348
|
148.03 Pg/mL
Geometric Coefficient of Variation 39.841
|
3787.47 Pg/mL
Geometric Coefficient of Variation 115.166
|
PRIMARY outcome
Timeframe: Up to Week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication and have any evaluable PK data
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
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=29 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
SUN-101 Via eFlow Nebulizer With Activated Charcoal
n=29 Participants
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
|
Seebri® Breezhaler®
n=28 Participants
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
Seebri® Breezhaler® With Activated Charcoal
n=26 Participants
: : 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
|
: Glycopyrrolate Injection
n=27 Participants
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to 24 Hours (AUC0_24)
|
172.23 hr*pg/mL
Geometric Coefficient of Variation 100.974
|
159.12 hr*pg/mL
Geometric Coefficient of Variation 92.720
|
472.35 hr*pg/mL
Geometric Coefficient of Variation 90.233
|
428.52 hr*pg/mL
Geometric Coefficient of Variation 46.985
|
1961.79 hr*pg/mL
Geometric Coefficient of Variation 142.488
|
PRIMARY outcome
Timeframe: Up to Week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
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.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=8 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
SUN-101 Via eFlow Nebulizer With Activated Charcoal
n=6 Participants
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
|
Seebri® Breezhaler®
n=15 Participants
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
Seebri® Breezhaler® With Activated Charcoal
n=10 Participants
: : 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
|
: Glycopyrrolate Injection
n=21 Participants
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Infinity (AUC0_infinity)
|
234.23 hr*pg/mL
Geometric Coefficient of Variation 77.206
|
167.84 hr*pg/mL
Geometric Coefficient of Variation 41.208
|
607.53 hr*pg/mL
Geometric Coefficient of Variation 79.340
|
570.90 hr*pg/mL
Geometric Coefficient of Variation 63.913
|
2550.85 hr*pg/mL
Geometric Coefficient of Variation 117.068
|
SECONDARY outcome
Timeframe: Up to Week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
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.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=21 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
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
|
Seebri® Breezhaler®
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
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
|
: Glycopyrrolate Injection
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Clearance (CL) for IV Infusion of 50 mcg of Glycopyrrolate
|
19.60 Liters/hr
Geometric Coefficient of Variation 117.068
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
calculated as Dose/(AUC0-inf\*λz). Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=21 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
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
|
Seebri® Breezhaler®
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
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
|
: Glycopyrrolate Injection
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Volume of Distribution During the Elimination Phase (Vz) for IV Infusion of 50 mcg of Glycopyrrolate
|
113.06 Liters
Geometric Coefficient of Variation 131.141
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
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.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=27 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
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
|
Seebri® Breezhaler®
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
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
|
: Glycopyrrolate Injection
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Time of Occurrence of Cmax (Tmax) for IV Infusion of 50 mcg of Glycopyrrolate
|
0.100 hr
Interval 0.08 to 0.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
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.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=21 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
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
|
Seebri® Breezhaler®
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
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
|
: Glycopyrrolate Injection
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Terminal Half Life (t1/2) for IV Infusion of 50 mcg of Glycopyrrolate
|
3.998 hr
Geometric Coefficient of Variation 111.8589
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
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.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=29 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
SUN-101 Via eFlow Nebulizer With Activated Charcoal
n=29 Participants
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
|
Seebri® Breezhaler®
n=28 Participants
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
Seebri® Breezhaler® With Activated Charcoal
n=26 Participants
: : 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
|
: Glycopyrrolate Injection
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
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-∞ -
|
182.59 hr*pg/mL
Geometric Coefficient of Variation 112.339
|
179.78 hr*pg/mL
Geometric Coefficient of Variation 108.906
|
524.18 hr*pg/mL
Geometric Coefficient of Variation 99.365
|
485.99 hr*pg/mL
Geometric Coefficient of Variation 56.588
|
—
|
SECONDARY outcome
Timeframe: up to week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
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.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=8 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
SUN-101 Via eFlow Nebulizer With Activated Charcoal
n=6 Participants
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
|
Seebri® Breezhaler®
n=15 Participants
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
Seebri® Breezhaler® With Activated Charcoal
n=10 Participants
: : 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
|
: Glycopyrrolate Injection
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Apparent Clearance Calculated as Dose/AUC0-INF After Extravascular Dose Administration of Seebri Breezhaler and SUN-101
|
213.47 L/hr
Geometric Coefficient of Variation 77.206
|
297.91 L/hr
Geometric Coefficient of Variation 41.208
|
103.70 L/hr
Geometric Coefficient of Variation 79.340
|
110.35 L/hr
Geometric Coefficient of Variation 63.913
|
—
|
SECONDARY outcome
Timeframe: up to week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
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
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=8 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
SUN-101 Via eFlow Nebulizer With Activated Charcoal
n=6 Participants
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
|
Seebri® Breezhaler®
n=15 Participants
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
Seebri® Breezhaler® With Activated Charcoal
n=10 Participants
: : 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
|
: Glycopyrrolate Injection
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) After Extravascular Dose Administration of Seebri Breezhaler and SUN-101
|
1263.63 liters
Geometric Coefficient of Variation 31.716
|
1668.59 liters
Geometric Coefficient of Variation 17.994
|
1305.30 liters
Geometric Coefficient of Variation 23.585
|
1708.81 liters
Geometric Coefficient of Variation 22.543
|
—
|
SECONDARY outcome
Timeframe: up to week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
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.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=29 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
SUN-101 Via eFlow Nebulizer With Activated Charcoal
n=29 Participants
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
|
Seebri® Breezhaler®
n=28 Participants
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
Seebri® Breezhaler® With Activated Charcoal
n=26 Participants
: : 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
|
: Glycopyrrolate Injection
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Time of Occurrence of Cmax (Tmax) for Seebri Breezhaler and SUN-101
|
0.317 hr
Interval 0.08 to 12.05
|
0.250 hr
Interval 0.07 to 12.3
|
0.250 hr
Interval 0.03 to 1.57
|
0.250 hr
Interval 0.05 to 0.4
|
—
|
SECONDARY outcome
Timeframe: up to week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
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.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=13 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
SUN-101 Via eFlow Nebulizer With Activated Charcoal
n=10 Participants
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
|
Seebri® Breezhaler®
n=20 Participants
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
Seebri® Breezhaler® With Activated Charcoal
n=20 Participants
: : 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
|
: Glycopyrrolate Injection
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Terminal Half Life (t1/2) for for Seebri Breezhaler and SUN-101
|
6.554 hr
Geometric Coefficient of Variation 135.6286
|
5.191 hr
Geometric Coefficient of Variation 61.4971
|
10.378 hr
Geometric Coefficient of Variation 80.1891
|
14.866 hr
Geometric Coefficient of Variation 69.3836
|
—
|
SECONDARY outcome
Timeframe: up to week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
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.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=29 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
SUN-101 Via eFlow Nebulizer With Activated Charcoal
n=29 Participants
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
|
Seebri® Breezhaler®
n=28 Participants
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
Seebri® Breezhaler® With Activated Charcoal
n=26 Participants
: : 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
|
: Glycopyrrolate Injection
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Dose Normalized Cmax for Seebri and SUN-101.
|
85.46 Pg/mL
Geometric Coefficient of Variation 51.746
|
78.33 Pg/mL
Geometric Coefficient of Variation 60.996
|
150.11 Pg/mL
Geometric Coefficient of Variation 76.348
|
133.22 Pg/mL
Geometric Coefficient of Variation 39.841
|
—
|
SECONDARY outcome
Timeframe: up to week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
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.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=29 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
SUN-101 Via eFlow Nebulizer With Activated Charcoal
n=29 Participants
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
|
Seebri® Breezhaler®
n=28 Participants
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
Seebri® Breezhaler® With Activated Charcoal
n=26 Participants
: : 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
|
: Glycopyrrolate Injection
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Dose Normalized Area Under the Curve Zero to 24 Hours (AUC0_24) for Seebri and SUN-101
|
273.85 hr*pg/mL
Geometric Coefficient of Variation 100.974
|
253.00 hr*pg/mL
Geometric Coefficient of Variation 92.720
|
425.12 hr*pg/mL
Geometric Coefficient of Variation 90.233
|
385.67 hr*pg/mL
Geometric Coefficient of Variation 46.985
|
—
|
SECONDARY outcome
Timeframe: up to week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
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.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=29 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
SUN-101 Via eFlow Nebulizer With Activated Charcoal
n=29 Participants
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
|
Seebri® Breezhaler®
n=28 Participants
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
Seebri® Breezhaler® With Activated Charcoal
n=26 Participants
: : 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
|
: Glycopyrrolate Injection
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Dose Normalized Area Under the Curve Zero to 48 Hours (AUC0_48) for Seebri and SUN-101
|
290.32 hr*pg/mL
Geometric Coefficient of Variation 112.339
|
285.85 hr*pg/mL
Geometric Coefficient of Variation 108.906
|
471.76 hr*pg/mL
Geometric Coefficient of Variation 99.365
|
437.39 hr*pg/mL
Geometric Coefficient of Variation 56.588
|
—
|
SECONDARY outcome
Timeframe: up to week 5Population: The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.
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.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=8 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
SUN-101 Via eFlow Nebulizer With Activated Charcoal
n=6 Participants
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
|
Seebri® Breezhaler®
n=15 Participants
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
Seebri® Breezhaler® With Activated Charcoal
n=10 Participants
: : 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
|
: Glycopyrrolate Injection
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Dose Normalized Area Under the Curve Zero From Zero to Infinity (AUC0_inf) for Seebri and SUN-101
|
372.42 hr*pg/mL
Geometric Coefficient of Variation 77.206
|
266.86 hr*pg/mL
Geometric Coefficient of Variation 41.208
|
546.78 hr*pg/mL
Geometric Coefficient of Variation 79.340
|
513.81 hr*pg/mL
Geometric Coefficient of Variation 63.931
|
—
|
SECONDARY outcome
Timeframe: Up to Week 5Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
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.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=29 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
SUN-101 Via eFlow Nebulizer With Activated Charcoal
n=29 Participants
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
|
Seebri® Breezhaler®
n=28 Participants
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
Seebri® Breezhaler® With Activated Charcoal
n=27 Participants
: : 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
|
: Glycopyrrolate Injection
n=27 Participants
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
The Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Adverse Events
|
6 participants
|
9 participants
|
7 participants
|
11 participants
|
7 participants
|
|
The Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Serious Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
The Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Adverse events leading to discontinuation
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to Week 5Population: Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.
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.
Outcome measures
| Measure |
SUN-101 Via eFlow Nebulizer
n=29 Participants
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
SUN-101 Via eFlow Nebulizer With Activated Charcoal
n=29 Participants
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
|
Seebri® Breezhaler®
n=28 Participants
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
Seebri® Breezhaler® With Activated Charcoal
n=27 Participants
: : 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
|
: Glycopyrrolate Injection
n=27 Participants
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
The Percentage of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Adverse events leading to discontinuation
|
3.4 percentage of participants
|
3.4 percentage of participants
|
0 percentage of participants
|
3.7 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Adverse Events
|
20.7 percentage of participants
|
31.0 percentage of participants
|
25.0 percentage of participants
|
40.7 percentage of participants
|
25.9 percentage of participants
|
|
The Percentage of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Serious Adverse Events
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
SUN-101 Via eFlow Nebulizer
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SUN-101 Via eFlow Nebulizer With Activated Charcoal
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Seebri® Breezhaler®
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Seebri® Breezhaler® With Activated Charcoal
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
: Glycopyrrolate Injection
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SUN-101 Via eFlow Nebulizer
n=29 participants at risk
50 mcg glycopyrrolate via Electronic Nebulizer
SUN-101 via eFlow nebulizer: 50 mcg glycopyrrolate via Electronic Nebulizer
|
SUN-101 Via eFlow Nebulizer With Activated Charcoal
n=29 participants at risk
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
|
Seebri® Breezhaler®
n=28 participants at risk
63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
Seebri® Breezhaler®: 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
|
Seebri® Breezhaler® With Activated Charcoal
n=27 participants at risk
: : 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
|
: Glycopyrrolate Injection
n=27 participants at risk
50 mcg glycopyrrolate via IV infusion
Glycopyrrolate Injection: 50 mcg glycopyrrolate via IV
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/29 • 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.
|
0.00%
0/29 • 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.
|
7.1%
2/28 • Number of events 2 • 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.
|
3.7%
1/27 • Number of events 1 • 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.
|
0.00%
0/27 • 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.
|
|
Nervous system disorders
headache
|
3.4%
1/29 • Number of events 1 • 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.
|
10.3%
3/29 • Number of events 3 • 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.
|
3.6%
1/28 • Number of events 1 • 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.
|
14.8%
4/27 • Number of events 4 • 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.
|
14.8%
4/27 • Number of events 4 • 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.
|
Additional Information
Respiratory Medical Director
Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER