Trial Outcomes & Findings for Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects (NCT NCT03075267)
NCT ID: NCT03075267
Last Updated: 2021-01-19
Results Overview
Maximum plasma concentration (Cmax) of Budesonide Day 1
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
96 participants
Primary outcome timeframe
Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose
Results posted on
2021-01-19
Participant Flow
This study was conducted at a single site in China.
Subjects were randomized in a 1:1:1 ratio to 1 of 3 treatments: BGF MDI 320/14.4/9.6 μg, BGF MDI 160/14.4/9.6 μg, or GFF MDI 14.4/9.6 μg.
Participant milestones
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
32
|
|
Overall Study
COMPLETED
|
31
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
Baseline Characteristics
Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects
Baseline characteristics by cohort
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Demographics
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Demographics
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 Demographics
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
Total
n=96 Demographics
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.1 Years
STANDARD_DEVIATION 3.8 • n=99 Participants
|
26.9 Years
STANDARD_DEVIATION 5.1 • n=107 Participants
|
24.7 Years
STANDARD_DEVIATION 4.1 • n=206 Participants
|
25.6 Years
STANDARD_DEVIATION 4.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
80 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Chinese subjects
|
32 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
96 Participants
n=7 Participants
|
|
Smoking Status
Non Smoker
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
87 Participants
n=7 Participants
|
|
Smoking Status
Former Smoker
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Weight
|
59.99 kg
STANDARD_DEVIATION 5.29 • n=99 Participants
|
60.00 kg
STANDARD_DEVIATION 6.13 • n=107 Participants
|
62.75 kg
STANDARD_DEVIATION 5.31 • n=206 Participants
|
60.91 kg
STANDARD_DEVIATION 5.68 • n=7 Participants
|
|
BMI
|
21.5 kg/m^2
STANDARD_DEVIATION 1.4 • n=99 Participants
|
21.6 kg/m^2
STANDARD_DEVIATION 1.2 • n=107 Participants
|
21.9 kg/m^2
STANDARD_DEVIATION 1.1 • n=206 Participants
|
21.7 kg/m^2
STANDARD_DEVIATION 1.2 • n=7 Participants
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Maximum plasma concentration (Cmax) of Budesonide Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) - Budesonide
|
459.308 pg/mL
Geometric Coefficient of Variation 67.6
|
224.298 pg/mL
Geometric Coefficient of Variation 98.1
|
—
|
PRIMARY outcome
Timeframe: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Maximum plasma concentration (Cmax) of Budesonide Day 8
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) - Budesonide
|
626.435 pg/mL
Geometric Coefficient of Variation 78.1
|
315.425 pg/mL
Geometric Coefficient of Variation 80.2
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Maximum plasma concentration (Cmax) of Glycopyrronium Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=31 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) - Glycopyrronium
|
4.884 pg/mL
Geometric Coefficient of Variation 92.5
|
5.286 pg/mL
Geometric Coefficient of Variation 120.8
|
5.674 pg/mL
Geometric Coefficient of Variation 113.4
|
PRIMARY outcome
Timeframe: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Maximum plasma concentration (Cmax) of Glycopyrronium Day 8
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) - Glycopyrronium
|
11.303 pg/mL
Geometric Coefficient of Variation 96.9
|
11.754 pg/mL
Geometric Coefficient of Variation 103.0
|
13.124 pg/mL
Geometric Coefficient of Variation 82.3
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Maximum plasma concentration (Cmax) of Formoterol Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) - Formoterol
|
9.651 pg/mL
Geometric Coefficient of Variation 55.8
|
9.932 pg/mL
Geometric Coefficient of Variation 71.9
|
10.618 pg/mL
Geometric Coefficient of Variation 76.6
|
PRIMARY outcome
Timeframe: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Maximum plasma concentration (Cmax) of Formoterol Day 8
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) - Formoterol
|
16.125 pg/mL
Geometric Coefficient of Variation 59.1
|
16.945 pg/mL
Geometric Coefficient of Variation 54.5
|
17.710 pg/mL
Geometric Coefficient of Variation 57.6
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide
|
1747.910 h*pg/mL
Geometric Coefficient of Variation 43.5
|
811.812 h*pg/mL
Geometric Coefficient of Variation 58.2
|
—
|
PRIMARY outcome
Timeframe: Day 8Population: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 8
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide
|
2509.888 h*pg/mL
Geometric Coefficient of Variation 53.4
|
1249.615 h*pg/mL
Geometric Coefficient of Variation 52.0
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=20 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=19 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=20 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium
|
29.400 h*pg/mL
Geometric Coefficient of Variation 23.5
|
27.197 h*pg/mL
Geometric Coefficient of Variation 41.3
|
29.002 h*pg/mL
Geometric Coefficient of Variation 42.6
|
PRIMARY outcome
Timeframe: Day 8Population: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 8
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=29 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=28 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=31 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium
|
69.487 h*pg/mL
Geometric Coefficient of Variation 64.8
|
77.078 h*pg/mL
Geometric Coefficient of Variation 47.5
|
72.636 h*pg/mL
Geometric Coefficient of Variation 57.2
|
PRIMARY outcome
Timeframe: Day 1Population: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=28 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol
|
47.843 h*pg/mL
Geometric Coefficient of Variation 35.0
|
46.492 h*pg/mL
Geometric Coefficient of Variation 39.3
|
53.583 h*pg/mL
Geometric Coefficient of Variation 38.0
|
PRIMARY outcome
Timeframe: Day 8Population: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 8
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol
|
81.936 h*pg/mL
Geometric Coefficient of Variation 39.5
|
85.322 h*pg/mL
Geometric Coefficient of Variation 34.0
|
83.499 h*pg/mL
Geometric Coefficient of Variation 37.8
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Time to maximum plasma concentration (tmax) - Budesonide Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) - Budesonide
|
0.333 h
Interval 0.1 to 2.0
|
0.333 h
Interval 0.1 to 2.0
|
—
|
PRIMARY outcome
Timeframe: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Time to maximum plasma concentration (tmax) - Budesonide Day 8
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) - Budesonide
|
0.333 h
Interval 0.1 to 4.0
|
0.333 h
Interval 0.03 to 4.0
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Time to maximum plasma concentration (tmax) - Glycopyrronium Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=31 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium
|
0.100 h
Interval 0.03 to 2.0
|
0.100 h
Interval 0.03 to 4.0
|
0.100 h
Interval 0.03 to 4.0
|
PRIMARY outcome
Timeframe: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Time to maximum plasma concentration (tmax) - Glycopyrronium Day 8
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium
|
0.333 h
Interval 0.03 to 4.0
|
0.333 h
Interval 0.03 to 4.0
|
0.333 h
Interval 0.03 to 2.0
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Time to maximum plasma concentration (tmax) - Formoterol Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) - Formoterol
|
0.833 h
Interval 0.1 to 2.0
|
0.100 h
Interval 0.1 to 2.0
|
0.100 h
Interval 0.1 to 2.0
|
PRIMARY outcome
Timeframe: Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Time to maximum plasma concentration (tmax) - Formoterol Day 8
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) - Formoterol
|
0.100 h
Interval 0.1 to 2.0
|
0.100 h
Interval 0.1 to 4.0
|
0.100 h
Interval 0.1 to 4.0
|
PRIMARY outcome
Timeframe: Day 1Population: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Budesonide Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Budesonide
|
1884.912 h*pg/mL
Geometric Coefficient of Variation 43.5
|
830.012 h*pg/mL
Geometric Coefficient of Variation 61.1
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Glycopyrronium Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=30 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=28 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Glycopyrronium
|
17.616 h*pg/mL
Geometric Coefficient of Variation 89.8
|
17.707 h*pg/mL
Geometric Coefficient of Variation 111.2
|
20.287 h*pg/mL
Geometric Coefficient of Variation 103.3
|
PRIMARY outcome
Timeframe: Day 1Population: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Formoterol Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Formoterol
|
48.326 h*pg/mL
Geometric Coefficient of Variation 41.4
|
47.408 h*pg/mL
Geometric Coefficient of Variation 48.2
|
45.950 h*pg/mL
Geometric Coefficient of Variation 78.1
|
PRIMARY outcome
Timeframe: Day 1Population: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Budesonide Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Budesonide
|
1936.211 h*pg/mL
Geometric Coefficient of Variation 42.0
|
876.673 h*pg/mL
Geometric Coefficient of Variation 58.8
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Glycopyrronium Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=5 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=1 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=3 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Glycopyrronium
|
35.465 h*pg/mL
Geometric Coefficient of Variation 19.6
|
33.014 h*pg/mL
Geometric Coefficient of Variation NA
value assessed on only one patient - no coefficient of variation
|
43.537 h*pg/mL
Geometric Coefficient of Variation 18.3
|
PRIMARY outcome
Timeframe: Day 1Population: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Formoterol Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=21 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=18 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=19 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Formoterol
|
61.617 h*pg/mL
Geometric Coefficient of Variation 37.5
|
73.123 h*pg/mL
Geometric Coefficient of Variation 40.5
|
70.608 h*pg/mL
Geometric Coefficient of Variation 46.0
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Elimination half-life (t½) - Budesonide Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Elimination Half-life (t½) - Budesonide
|
4.572 h
Geometric Coefficient of Variation 25.3
|
3.168 h
Geometric Coefficient of Variation 31.9
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Elimination half-life (t½) - Glycopyrronium Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=20 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=14 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=15 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Elimination Half-life (t½) - Glycopyrronium
|
5.676 h
Geometric Coefficient of Variation 52.5
|
8.539 h
Geometric Coefficient of Variation 161.3
|
6.194 h
Geometric Coefficient of Variation 108.2
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Elimination half-life (t½) - Formoterol Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=28 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Elimination Half-life (t½) - Formoterol
|
5.098 h
Geometric Coefficient of Variation 22.7
|
5.657 h
Geometric Coefficient of Variation 38.1
|
5.628 h
Geometric Coefficient of Variation 34.2
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Apparent total body clearance (CL/F) - Budesonide Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Apparent Total Body Clearance (CL/F) - Budesonide
|
165.271 L/h
Geometric Coefficient of Variation 42.0
|
182.508 L/h
Geometric Coefficient of Variation 58.8
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Apparent total body clearance (CL/F) - Glycopyrronium Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=5 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=1 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=3 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Apparent Total Body Clearance (CL/F) - Glycopyrronium
|
406.038 L/h
Geometric Coefficient of Variation 19.6
|
436.184 L/h
Geometric Coefficient of Variation NA
value assessed on only one patient - no coefficient of variation
|
330.757 L/h
Geometric Coefficient of Variation 18.3
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Apparent total body clearance (CL/F) - Formoterol Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=21 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=18 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=19 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Apparent Total Body Clearance (CL/F) - Formoterol
|
155.801 L/h
Geometric Coefficient of Variation 37.5
|
131.286 L/h
Geometric Coefficient of Variation 40.5
|
135.962 L/h
Geometric Coefficient of Variation 46.0
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Apparent volume of distribution (Vd/F) - Budesonide - Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F) - Budesonide
|
1090.237 L
Geometric Coefficient of Variation 43.0
|
834.269 L
Geometric Coefficient of Variation 56.2
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Apparent volume of distribution (Vd/F) - Glycopyrronium - Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=5 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=1 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=3 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F) - Glycopyrronium
|
2172.038 L
Geometric Coefficient of Variation 17.6
|
2123.999 L
Geometric Coefficient of Variation NA
value assessed on only one patient - no coefficient of variation
|
1864.314 L
Geometric Coefficient of Variation 49.8
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Apparent volume of distribution (Vd/F) - Formoterol - Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=21 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=18 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=19 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Apparent Volume of Distribution (Vd/F) - Formoterol
|
1125.215 L
Geometric Coefficient of Variation 26.0
|
1000.172 L
Geometric Coefficient of Variation 29.2
|
1035.257 L
Geometric Coefficient of Variation 30.9
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Terminal elimination rate constant (λz) - Budesonide - Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Terminal Elimination Rate Constant (λz) - Budesonide
|
0.152 1/h
Geometric Coefficient of Variation 25.3
|
0.219 1/h
Geometric Coefficient of Variation 31.9
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Terminal elimination rate constant (λz) - Glycopyrronium - Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=20 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=14 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=15 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Terminal Elimination Rate Constant (λz) - Glycopyrronium
|
0.122 1/h
Geometric Coefficient of Variation 52.5
|
0.081 1/h
Geometric Coefficient of Variation 161.3
|
0.112 1/h
Geometric Coefficient of Variation 108.2
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Terminal elimination rate constant (λz) - Formoterol - Day 1
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=28 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Terminal Elimination Rate Constant (λz) - Formoterol
|
0.136 1/h
Geometric Coefficient of Variation 22.7
|
0.123 1/h
Geometric Coefficient of Variation 38.1
|
0.123 1/h
Geometric Coefficient of Variation 34.2
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Accumulation ratio for Cmax (RAC \[Cmax\]) - Budesonide
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Accumulation Ratio for Cmax (RAC [Cmax]) - Budesonide
|
1.400 Ratio
Geometric Coefficient of Variation 71.4
|
1.406 Ratio
Geometric Coefficient of Variation 62.6
|
—
|
PRIMARY outcome
Timeframe: Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose and Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dosePopulation: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Accumulation ratio for Cmax (RAC \[Cmax\]) - Glycopyrronium
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=31 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Accumulation Ratio for Cmax (RAC [Cmax]) - Glycopyrronium
|
2.383 Ratio
Geometric Coefficient of Variation 86.4
|
2.319 Ratio
Geometric Coefficient of Variation 90.3
|
2.412 Ratio
Geometric Coefficient of Variation 89.7
|
PRIMARY outcome
Timeframe: Day 1 and Day 8Population: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Accumulation ratio for Cmax (RAC \[Cmax\]) - Formoterol
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol
|
1.678 Ratio
Geometric Coefficient of Variation 50.1
|
1.706 Ratio
Geometric Coefficient of Variation 42.1
|
1.668 Ratio
Geometric Coefficient of Variation 62.2
|
PRIMARY outcome
Timeframe: Day 1 and Day 8Population: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Accumulation ratio for AUC 0-12 (RAC \[AUC 0-12\]) - Budesonide
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide
|
1.455 Ratio
Geometric Coefficient of Variation 45.9
|
1.539 Ratio
Geometric Coefficient of Variation 37.1
|
—
|
PRIMARY outcome
Timeframe: Day 1 and Day 8Population: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Accumulation ratio for AUC 0-12 (RAC \[AUC 0-12\]) - Glycopyrronium
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=18 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=18 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=19 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium
|
3.324 Ratio
Geometric Coefficient of Variation 47.5
|
3.030 Ratio
Geometric Coefficient of Variation 43.0
|
3.189 Ratio
Geometric Coefficient of Variation 31.5
|
PRIMARY outcome
Timeframe: Day 1 and Day 8Population: PK Population - defined as all subjects in the Safety Population who had sufficient data to reliably calculate at least 1 PK parameter and did not have a major protocol deviation
Accumulation ratio for AUC 0-12 (RAC \[AUC 0-12\]) - Formoterol
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=31 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=28 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol
|
1.718 Ratio
Geometric Coefficient of Variation 28.7
|
1.835 Ratio
Geometric Coefficient of Variation 26.2
|
1.620 Ratio
Geometric Coefficient of Variation 27.5
|
SECONDARY outcome
Timeframe: Visit 4, Day 8Population: Safety Population
Number of subjects with clinically significant changes in post baseline physical exam findings
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Physical Exam Findings
Significant Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 4, Day 8Population: Safety Population
Number of subjects with clinically significant changes in post baseline laboratory tests
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Laboratory Tests
Potassium
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 4, Day 8Population: Safety Population
Number of subjects with clinically significant changes in post baseline electrocardiogram
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Electrocardiogram
Significant electrocardiogram changes
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 4, Day 8Population: Safety Population
Number of subjects with clinically significant changes in post baseline serious TEAEs (treatment-emergent adverse events) or TEAEs leading to withdrawal
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Serious Adverse Events/Adverse Events
Serious TEAEs/TEAEs leading to withdrawal
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 4, Day 8Population: Safety Population
Number of subjects with clinically significant changes in post baseline vital signs
Outcome measures
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 Participants
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 Participants
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Vital Signs
Bradycardia events
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
PT010 (BGF MDI) 320/14.4/9.6 µg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
PT010 (BGF MDI) 160/14.4/9.6 µg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
PT003 (GFF MDI) 14.4/9.6 µg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PT010 (BGF MDI) 320/14.4/9.6 µg
n=32 participants at risk
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
|
PT010 (BGF MDI) 160/14.4/9.6 µg
n=32 participants at risk
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
|
PT003 (GFF MDI) 14.4/9.6 µg
n=32 participants at risk
PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg
|
|---|---|---|---|
|
Investigations
Blood glucose increased
|
12.5%
4/32 • Number of events 4 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
9.4%
3/32 • Number of events 3 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
12.5%
4/32 • Number of events 4 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
|
Investigations
Blood potassium increased
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
3.1%
1/32 • Number of events 2 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
15.6%
5/32 • Number of events 5 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
|
Investigations
Blood potassium decreased
|
6.2%
2/32 • Number of events 3 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
12.5%
4/32 • Number of events 4 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/32 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/32 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
|
Investigations
Blood uric acid increased
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
0.00%
0/32 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/32 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
0.00%
0/32 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
|
Investigations
Blood glucose decreased
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
0.00%
0/32 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
0.00%
0/32 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
9.4%
3/32 • Number of events 3 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
12.5%
4/32 • Number of events 4 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.2%
2/32 • Number of events 2 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
6.2%
2/32 • Number of events 3 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
|
General disorders
Sensation of foreign body
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
9.4%
3/32 • Number of events 3 • Adverse Events were collected from the first administration of study drug through the Final Telephone Follow-up.
The Safety Population was defined as all subjects who receive at least one dose of any blinded study drug. Serious Adverse Events were collected from the first administration of study drug up to 14 days following the last dose of study drug administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The study site will have the opportunity to publish the results of the study, provided that the sponsor has had the opportunity to review and comment on the study site's proposed publication prior to its being submitted for publication with the prior advice of legal (intellectual property counsel) and with proper regard to the protection of subjects' identities.
- Publication restrictions are in place
Restriction type: OTHER