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Trial Outcomes & Findings for PK Study of PT003 and PT001 in Japanese Healthy Subjects (NCT NCT02196714)

NCT ID: NCT02196714

Last Updated: 2017-04-26

Results Overview

Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

Day 1

Results posted on

2017-04-26

Participant Flow

Conducted at 1 site from July 2014 - September 2014. Study duration for each subject was between 33 and 98 days.

Study was four-period, four-treatment, complete cross-over design in healthy adult Japanese Subjects. Each treatment visit was followed by a minimum 7 day to maximum 14 day washout period between treatments.

Participant milestones

Participant milestones
Measure
Received GFF MDI 28.8/9.6 μg
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 μg
Received GFF MDI 14.4/9.6 μg
Received GFF MDI 14.4/9.6 μg
Received GP MDI 28.8 μg
Glycopyrronium (GP) Metered Dose Inhaler (MDI) 28.8 μg
Received GP MDI 14.4 μg
Received GP MDI 14.4 μg
Overall Study
STARTED
24
23
24
24
Overall Study
COMPLETED
24
23
23
24
Overall Study
NOT COMPLETED
0
0
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Received GFF MDI 28.8/9.6 μg
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 μg
Received GFF MDI 14.4/9.6 μg
Received GFF MDI 14.4/9.6 μg
Received GP MDI 28.8 μg
Glycopyrronium (GP) Metered Dose Inhaler (MDI) 28.8 μg
Received GP MDI 14.4 μg
Received GP MDI 14.4 μg
Overall Study
Protocol Violation
0
0
1
0

Baseline Characteristics

PK Study of PT003 and PT001 in Japanese Healthy Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Subjects
n=24 Participants
Analysis Set: All Subjects Randomized
Age, Continuous
29.8 Years
STANDARD_DEVIATION 6.5 • n=93 Participants
Sex: Female, Male
Female
11 Participants
n=93 Participants
Sex: Female, Male
Male
13 Participants
n=93 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=22 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
n=23 Participants
GP MDI 14.4 µg
Cmax
16.85 pg/mL
Full Range 4.26 • Interval 4.09 to 56.4
15.23 pg/mL
Full Range 7.69 • Interval 2.11 to 38.8
9.09 pg/mL
Full Range 6.5 • Interval 2.25 to 27.8
7.26 pg/mL
Interval 2.51 to 16.1

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Cmax
—
10.74 pg/mL
Full Range 3.46 • Interval 3.18 to 16.2
11.99 pg/mL
Full Range 7.07 • Interval 3.95 to 30.9
—

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=22 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
n=23 Participants
GP MDI 14.4 µg
AUC 0-12
50.59 h*pg/mL
Full Range 10.75 • Interval 13.57 to 108.54
45.43 h*pg/mL
Full Range 19.43 • Interval 11.31 to 83.76
21.75 h*pg/mL
Full Range 9.00 • Interval 3.71 to 43.16
24.72 h*pg/mL
Interval 7.63 to 51.06

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
AUC 0-12
—
44.15 h*pg/mL
Full Range 15.3 • Interval 10.59 to 79.35
42.54 h*pg/mL
Full Range 12.04 • Interval 17.88 to 62.21
—

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=22 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
n=23 Participants
GP MDI 14.4 µg
AUC 0-t
64.05 h*pg/mL
Full Range 17.61 • Interval 9.69 to 146.37
53.52 h*pg/mL
Full Range 3.31 • Interval 7.11 to 122.09
21.37 h*pg/mL
Full Range 14.53 • Interval 1.49 to 58.08
23.72 h*pg/mL
Interval 5.27 to 68.02

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
AUC 0-t
—
45.96 h*pg/mL
Full Range 19.85 • Interval 7.94 to 107.41
42.39 h*pg/mL
Full Range 14.69 • Interval 14.93 to 69.75
—

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=2 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=7 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=2 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
n=3 Participants
GP MDI 14.4 µg
AUC 0-∞
37.32 h*pg/mL
Interval 32.36 to 42.28
46.26 h*pg/mL
Interval 29.58 to 60.11
32.18 h*pg/mL
Interval 30.24 to 34.13
34.04 h*pg/mL
Interval 33.67 to 34.64

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=16 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=11 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
AUC 0-∞
—
61.88 h*pg/mL
Full Range 21.60 • Interval 41.27 to 126.07
61.43 h*pg/mL
Full Range 12.01 • Interval 45.43 to 82.84
—

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population

Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=22 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
n=23 Participants
GP MDI 14.4 µg
Tmax
0.10 h
Interval 0.03 to 2.0
0.10 h
Interval 0.03 to 4.02
0.10 h
Interval 0.03 to 0.1
0.10 h
Interval 0.03 to 4.1

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population

Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Tmax
—
0.10 h
Interval 0.1 to 1.0
0.10 h
Interval 0.1 to 2.0
—

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=10 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=14 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=14 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
n=13 Participants
GP MDI 14.4 µg
T 1/2
24.87 h
Full Range 51.77 • Interval 2.14 to 103.21
9.49 h
Full Range 11.98 • Interval 2.88 to 37.9
4.14 h
Full Range 1.40 • Interval 1.31 to 6.89
19.13 h
Interval 2.08 to 191.29

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=21 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=20 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
T 1/2
—
5.45 h
Full Range 2.39 • Interval 3.11 to 14.36
5.25 h
Full Range 2.32 • Interval 3.24 to 13.87
—

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=2 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=7 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=2 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
n=3 Participants
GP MDI 14.4 µg
CL/F
785.60 L/h
Interval 681.2 to 890.0
657.91 L/h
Interval 479.15 to 973.62
449.10 L/h
Interval 421.97 to 476.24
423.12 L/h
Interval 415.74 to 427.7

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=7 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=2 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
CL/F
—
168.95 L/h
Full Range 45.28 • Interval 76.15 to 232.63
161.55 L/h
Full Range 30.17 • Interval 151.89 to 211.32
—

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=2 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=7 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=2 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
n=3 Participants
GP MDI 14.4 µg
Vd/F
3555.88 L
Interval 3509.62 to 3602.14
3508.00 L
Interval 2089.69 to 4654.28
2577.78 L
Interval 2475.12 to 2680.44
2101.03 L
Interval 1929.07 to 2193.02

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=7 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=2 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Vd/F
—
1187.75 L
Full Range 313.20 • Interval 516.4 to 1779.88
1054.16 L
Full Range 225.15 • Interval 828.09 to 1618.22
—

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=10 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=14 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=14 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
n=13 Participants
GP MDI 14.4 µg
Lambda z
0.1100 1/h
Full Range 4.26 • Interval 0.0067 to 0.3242
0.1506 1/h
Full Range 7.69 • Interval 0.0183 to 0.2404
0.1983 1/h
Full Range 6.5 • Interval 0.1007 to 0.5299
0.1614 1/h
Interval 0.0036 to 0.3333

PRIMARY outcome

Timeframe: Day 1

Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)

Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=14 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=14 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Lambda z
—
0.1412 1/h
Full Range 0.0381 • Interval 0.0483 to 0.2225
0.1470 1/h
Full Range 0.0410 • Interval 0.05 to 0.214
—

SECONDARY outcome

Timeframe: 12 Hours

Population: Safety Population

Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Basophils (10^9cells/L)
0.001 10^9cells/L
Standard Deviation 0.028
0.007 10^9cells/L
Standard Deviation 0.025
0.000 10^9cells/L
Standard Deviation 0.022
—
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Eosinophils (10^9cells/L)
0.065 10^9cells/L
Standard Deviation 0.103
0.044 10^9cells/L
Standard Deviation 0.048
0.033 10^9cells/L
Standard Deviation 0.068
—
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Granulocytes (10^9cells/L)
0.443 10^9cells/L
Standard Deviation 1.278
0.222 10^9cells/L
Standard Deviation 1.436
0.483 10^9cells/L
Standard Deviation 1.793
—
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Leukocytes (10^9cells/L)
0.800 10^9cells/L
Standard Deviation 1.526
0.484 10^9cells/L
Standard Deviation 1.710
0.780 10^9cells/L
Standard Deviation 1.990
—
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Lymphocytes (10^9cells/L)
0.235 10^9cells/L
Standard Deviation 0.383
0.147 10^9cells/L
Standard Deviation 0.390
0.206 10^9cells/L
Standard Deviation 0.402
—
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Monocytes (10^9cells/L)
0.055 10^9cells/L
Standard Deviation 0.103
0.065 10^9cells/L
Standard Deviation 0.084
0.056 10^9cells/L
Standard Deviation 0.115
—
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Platelets (10^9cells/L)
-23.1 10^9cells/L
Standard Deviation 26.6
-22.4 10^9cells/L
Standard Deviation 24.5
-14.4 10^9cells/L
Standard Deviation 16.2
—

SECONDARY outcome

Timeframe: 12 Hours

Population: Safety Population

Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Basophils/leukocytes (ratio)
-0.0013 Ratio
Standard Deviation 0.0039
-0.0001 Ratio
Standard Deviation 0.0044
-0.0013 Ratio
Standard Deviation 0.0040
—
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Eosinophils/leukocytes (ratio)
0.0046 Ratio
Standard Deviation 0.0091
0.0034 Ratio
Standard Deviation 0.0089
0.0026 Ratio
Standard Deviation 0.0131
—
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Granulocytes/leukocytes (ratio)
-0.0010 Ratio
Standard Deviation 0.0759
0.0043 Ratio
Standard Deviation 0.0688
0.0003 Ratio
Standard Deviation 0.0818
—
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Hematocrit (ratio)
-0.043 Ratio
Standard Deviation 0.023
-0.040 Ratio
Standard Deviation 0.022
-0.041 Ratio
Standard Deviation 0.030
—
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Lymphocytes/leukocytes (ratio)
-0.0018 Ratio
Standard Deviation 0.0616
-0.0110 Ratio
Standard Deviation 0.0565
-0.0019 Ratio
Standard Deviation 0.0662
—
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Monocytes/leukocytes (ratio)
-0.0006 Ratio
Standard Deviation 0.0118
0.0034 Ratio
Standard Deviation 0.0125
0.0004 Ratio
Standard Deviation 0.0136
—

SECONDARY outcome

Timeframe: 12 Hours

Population: Safety Population

Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Ery. mean corpuscuar HGB (g/L)
11.4 g/L
Standard Deviation 15.2
12.0 g/L
Standard Deviation 15.5
8.5 g/L
Standard Deviation 13.9
—
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Hemoglobin (g/L)
-10.38 g/L
Standard Deviation 9.10
-8.81 g/L
Standard Deviation 7.76
-10.61 g/L
Standard Deviation 9.10
—

SECONDARY outcome

Timeframe: 12 Hours

Population: Safety Population

Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar volume)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
-0.9 fL
Standard Deviation 0.8
-0.9 fL
Standard Deviation 0.6
-0.8 fL
Standard Deviation 0.9
—

SECONDARY outcome

Timeframe: 12 Hours

Population: Safety Population

Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar hemoglobin)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
0.75 pg/cell
Standard Deviation 1.22
0.78 pg/cell
Standard Deviation 1.29
0.49 pg/cell
Standard Deviation 1.08
—

SECONDARY outcome

Timeframe: 12 Hours

Population: Safety Population

Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Erythrocytes)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
-0.433 10^12cells/L
Standard Deviation 0.253
-0.391 10^12cells/L
Standard Deviation 0.242
-0.419 10^12cells/L
Standard Deviation 0.326
—

SECONDARY outcome

Timeframe: 12 hours

Population: Safety Population

Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
ALT (IU/L)
-2.4 IU/L
Standard Deviation 3.9
-3.1 IU/L
Standard Deviation 4.3
-1.7 IU/L
Standard Deviation 3.1
—
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Alkaline phosphatase (IU/L)
-6.0 IU/L
Standard Deviation 3.1
-5.2 IU/L
Standard Deviation 4.3
-5.0 IU/L
Standard Deviation 5.1
—
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
AST (IU/L)
-3.7 IU/L
Standard Deviation 3.0
-4.2 IU/L
Standard Deviation 3.7
-3.3 IU/L
Standard Deviation 2.6
—
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Gamma glutamyl transferase (IU/L)
-2.2 IU/L
Standard Deviation 1.9
-2.5 IU/L
Standard Deviation 2.4
-1.6 IU/L
Standard Deviation 1.9
—

SECONDARY outcome

Timeframe: 12 hours

Population: Safety Population

Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Albumin (g/L)
-6.7 g/L
Standard Deviation 2.4
-7.1 g/L
Standard Deviation 2.9
-6.9 g/L
Standard Deviation 4.1
—
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Protein (g/L)
-10.3 g/L
Standard Deviation 4.3
-10.9 g/L
Standard Deviation 5.3
-10.8 g/L
Standard Deviation 6.7
—

SECONDARY outcome

Timeframe: 12 hours

Population: Safety Population

Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Blood urea nitrogen (mmol/L)
0.74 mmol/L
Standard Deviation 1.51
0.01 mmol/L
Standard Deviation 1.45
0.34 mmol/L
Standard Deviation 1.32
—
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Calcium (mmol/L)
-0.13 mmol/L
Standard Deviation 0.06
-0.15 mmol/L
Standard Deviation 0.09
-0.14 mmol/L
Standard Deviation 0.12
—
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Chloride (mmol/L)
2.3 mmol/L
Standard Deviation 1.5
3.0 mmol/L
Standard Deviation 2.3
2.5 mmol/L
Standard Deviation 1.8
—
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Magnesium (mmol/L)
-0.04 mmol/L
Standard Deviation 0.20
-0.05 mmol/L
Standard Deviation 0.09
-0.07 mmol/L
Standard Deviation 0.09
—
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Phosphorus (mmol/L)
0.133 mmol/L
Standard Deviation 0.164
0.135 mmol/L
Standard Deviation 0.165
0.163 mmol/L
Standard Deviation 0.132
—
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Sodium (mmol/L)
0.1 mmol/L
Standard Deviation 1.6
0.9 mmol/L
Standard Deviation 2.1
0.5 mmol/L
Standard Deviation 1.3
—

SECONDARY outcome

Timeframe: 12 hours

Population: Safety Population

Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Direct bilirubin (μmol/L)
-2.64 μmol/L
Standard Deviation 2.14
-3.06 μmol/L
Standard Deviation 1.75
-2.53 μmol/L
Standard Deviation 1.45
—
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Creatinine (μmol/L)
3.61 μmol/L
Standard Deviation 13.41
1.88 μmol/L
Standard Deviation 11.14
4.92 μmol/L
Standard Deviation 15.74
—
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Iron (μmol/L)
-2.58949 μmol/L
Standard Deviation 8.19974
-5.42524 μmol/L
Standard Deviation 8.9
-2.81888 μmol/L
Standard Deviation 7.07702
—
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Total bilirubin (μmol/L)
-7.20 μmol/L
Standard Deviation 5.92
-8.19 μmol/L
Standard Deviation 5.68
-7.14 μmol/L
Standard Deviation 4.80
—

SECONDARY outcome

Timeframe: 12 hours

Population: Safety Population

Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (eGFR)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
-3.5 mL/min/1.73m2
Standard Deviation 15.3
-4.2 mL/min/1.73m2
Standard Deviation 13.2
-7.2 mL/min/1.73m2
Standard Deviation 16.6
—

SECONDARY outcome

Timeframe: 12 hours

Population: Safety Population

Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ferritin)

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
-11.669 μg/L
Standard Deviation 9.731
-14.169 μg/L
Standard Deviation 13.912
-11.949 μg/L
Standard Deviation 12.306
—

SECONDARY outcome

Timeframe: 12 hours

Population: Safety Population

Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose
Glucose (mmol/L) 30 minutes post-dose
-0.01 mmol/L
Interval -0.4 to 0.7
-0.03 mmol/L
Interval -0.3 to 0.6
-0.08 mmol/L
Interval -0.8 to 0.5
—
Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose
Glucose (mmol/L) 2 hours post-dose
-0.06 mmol/L
Interval -0.4 to 0.7
0.05 mmol/L
Interval -0.3 to 0.4
-0.01 mmol/L
Interval -0.7 to 0.8
—
Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose
Glucose (mmol/L) 4 hours post-dose
-0.16 mmol/L
Interval -0.6 to 0.7
-0.08 mmol/L
Interval -0.5 to 0.4
-0.24 mmol/L
Interval -0.8 to 0.4
—
Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose
Glucose (mmol/L) 12 hours post-dose
0.23 mmol/L
Interval -0.3 to 0.9
0.10 mmol/L
Interval -0.4 to 0.7
0.18 mmol/L
Interval -0.8 to 0.8
—
Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose
Potassium (mmol/L) 30 minutes post-dose
0.06 mmol/L
Interval -0.5 to 0.9
0.01 mmol/L
Interval -0.3 to 1.0
0.00 mmol/L
Interval -0.6 to 0.5
—
Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose
Potassium (mmol/L) 2 hours post-dose
0.10 mmol/L
Interval -0.4 to 2.4
-0.02 mmol/L
Interval -0.5 to 0.8
-0.07 mmol/L
Interval -0.5 to 0.4
—
Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose
Potassium (mmol/L) 4 hours post-dose
-0.07 mmol/L
Interval -0.6 to 0.4
-0.01 mmol/L
Interval -0.6 to 1.0
-0.12 mmol/L
Interval -0.5 to 0.4
—
Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose
Potassium (mmol/L) 12 hours post-dose
0.07 mmol/L
Interval -0.5 to 1.0
0.05 mmol/L
Interval -0.5 to 0.7
-0.06 mmol/L
Interval -0.6 to 0.4
—

SECONDARY outcome

Timeframe: 12 hours

Population: Safety Population

Change in Heart Rate from Pre-dose to 12 hours Post dose

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in Heart Rate From Pre-dose to 12 Hours Post Dose
4.5 Beats/Min
Interval -13.0 to 29.0
11.3 Beats/Min
Interval 2.0 to 42.0
9.3 Beats/Min
Interval -4.0 to 36.0
—

SECONDARY outcome

Timeframe: 12 hours

Population: Safety Population

Change in PR Interval from Pre-dose to 12 hours Post dose

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in PR Interval From Pre-dose to 12 Hours Post Dose
-7.4 msec
Interval -36.0 to 6.0
-10.7 msec
Interval -22.0 to 6.0
-8.5 msec
Interval -46.0 to 14.0
—

SECONDARY outcome

Timeframe: 12 hours

Population: Safety Population

Change in QRS axis from Pre-dose to 12 hours Post dose

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in QRS Axis From Pre-dose to 12 Hours Post Dose
0.0 QRS axis
Interval -21.0 to 16.0
-0.5 QRS axis
Interval -20.0 to 15.0
4.1 QRS axis
Interval -11.0 to 76.0
—

SECONDARY outcome

Timeframe: 12 hours

Population: Safety Population

Change in QRS duration from Pre-dose to 12 hours Post dose

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in QRS Duration From Pre-dose to 12 Hours Post Dose
-4.0 msec
Interval -22.0 to 4.0
-3.9 msec
Interval -24.0 to 8.0
-1.1 msec
Interval -14.0 to 6.0
—

SECONDARY outcome

Timeframe: 12 hours

Population: Safety Population

Change in QT Interval from Pre-dose to 12 hours Post dose

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in QT Interval From Pre-dose to 12 Hours Post Dose
-20.5 msec
Interval -72.0 to 24.0
-28.5 msec
Interval -64.0 to 0.0
-24.8 msec
Interval -78.0 to 0.0
—

SECONDARY outcome

Timeframe: 12 hours

Population: Safety Population

Change in QTc Bazett Interval from Pre-dose to 12 hours Post dose

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose
-5.8 msec
Interval -28.0 to 10.0
7.2 msec
Interval -14.0 to 40.0
4.4 msec
Interval -26.0 to 30.0
—

SECONDARY outcome

Timeframe: 12 hours

Population: Safety Population

Change in QTc Fridericia's Interval from Pre-dose to 12 hours Post dose

Outcome measures

Outcome measures
Measure
GP MDI 28.8 ug
n=24 Participants
GP MDI 28.8 ug
GFF MDI 28.8/9.6 ug
n=24 Participants
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 Participants
GFF MDI 14.4/9.6 ug
GP MDI 14.4 µg
GP MDI 14.4 µg
Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose
-10.8 msec
Interval -29.0 to 5.0
-4.8 msec
Interval -17.0 to 11.0
-5.4 msec
Interval -27.0 to 16.0
—

Adverse Events

GFF MDI 28.8/9.6 ug

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

GFF MDI 14.4/9.6 ug

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

GP MDI 28.8 ug

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

GP MDI 14.4 µg

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
GFF MDI 28.8/9.6 ug
n=24 participants at risk
Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
GFF MDI 14.4/9.6 ug
n=23 participants at risk
GFF MDI 14.4/9.6 ug
GP MDI 28.8 ug
n=24 participants at risk
GP MDI 28.8 ug
GP MDI 14.4 µg
n=24 participants at risk
GP MDI 14.4 µg
Blood and lymphatic system disorders
Anaemia
0.00%
0/24 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
8.7%
2/23 • Number of events 2 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
4.2%
1/24 • Number of events 1 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
8.3%
2/24 • Number of events 2 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
Nervous system disorders
Dizziness
0.00%
0/24 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
8.7%
2/23 • Number of events 2 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
8.3%
2/24 • Number of events 2 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
0.00%
0/24 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
Nervous system disorders
Headache
0.00%
0/24 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
8.7%
2/23 • Number of events 2 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
4.2%
1/24 • Number of events 1 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
4.2%
1/24 • Number of events 1 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
Nervous system disorders
Somnolence
8.3%
2/24 • Number of events 2 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
0.00%
0/23 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
0.00%
0/24 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
0.00%
0/24 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
Reproductive system and breast disorders
Dysmenorrhoea
0.00%
0/24 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
8.7%
2/23 • Number of events 2 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
0.00%
0/24 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.
4.2%
1/24 • Number of events 1 • Adverse Events were collected from Day 0 (Randomization visit and first dose) through Final Follow-up Visit, which is 7-14 days post final dose.
Serious Adverse Events collected from time subject signs ICF, up to 14 days following the last dose of study drug.

Additional Information

Colin Reisner, MD, FCCP, FAAAAI

Pearl Therapeutics Inc.

Phone: 650-305-2600

Results disclosure agreements

  • Principal investigator is a sponsor employee Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
  • Publication restrictions are in place

Restriction type: OTHER