COPD
Conditions
Keywords
Japanese Healthy Volunteers
Brief summary
A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over, Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.
Interventions
DRUGGlycopyrronium and Formoterol Fumarate (GFF) Dose 1
Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)
DRUGGlycopyrronium and Formoterol Fumarate (GFF) Dose 2
Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)
DRUGGlycopyrronium (GP) Dose 1
Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)
DRUGGlycopyrronium (GP) Dose 2
Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)
Sponsors
Pearl Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Informed Consent Form (ICF) prior to any study related procedures * Male and female first generation Japanese subjects 18 to 45 years, inclusive * Good general health * Medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential * Clinical labs within normal ranges or determined to be not clinically significant by the Investigator
Exclusion criteria
* Pregnancy, nursing female subjects, or subjects trying to conceive * Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study * History of ECG abnormalities * Cancer not in complete remission for at least 5 years * Clinically significant, symptomatic prostatic hypertrophy * Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening * Clinically significant bladder neck obstruction or urinary retention * Inadequately treated glaucoma * History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study * Subjects with pre-existing anemia and/or iron deficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Day 1 | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax) |
| AUC 0-12 | Day 1 | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12) |
| AUC 0-t | Day 1 | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t) |
| AUC 0-∞ | Day 1 | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞) |
| Tmax | Day 1 | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax) |
| T 1/2 | Day 1 | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2) |
| CL/F | Day 1 | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment |
| Vd/F | Day 1 | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment |
| Lambda z | Day 1 | Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | 12 Hours | Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose |
| Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose | 12 hours | Change in QTc Fridericia's Interval from Pre-dose to 12 hours Post dose |
| Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | 12 hours | Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose |
| Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | 12 hours | Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose |
| Change in Heart Rate From Pre-dose to 12 Hours Post Dose | 12 hours | Change in Heart Rate from Pre-dose to 12 hours Post dose |
| Change in PR Interval From Pre-dose to 12 Hours Post Dose | 12 hours | Change in PR Interval from Pre-dose to 12 hours Post dose |
| Change in QRS Axis From Pre-dose to 12 Hours Post Dose | 12 hours | Change in QRS axis from Pre-dose to 12 hours Post dose |
| Change in QRS Duration From Pre-dose to 12 Hours Post Dose | 12 hours | Change in QRS duration from Pre-dose to 12 hours Post dose |
| Change in QT Interval From Pre-dose to 12 Hours Post Dose | 12 hours | Change in QT Interval from Pre-dose to 12 hours Post dose |
| Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose | 12 hours | Change in QTc Bazett Interval from Pre-dose to 12 hours Post dose |
Countries
United States
Participant flow
Recruitment details
Conducted at 1 site from July 2014 - September 2014. Study duration for each subject was between 33 and 98 days.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Analysis Set: All Subjects Randomized | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 29.8 Years STANDARD_DEVIATION 6.5 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 24 | 8 / 23 | 4 / 24 | 4 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 23 | 0 / 24 | 0 / 24 |
Outcome results
Primary
AUC 0-∞
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | AUC 0-∞ | 61.88 h*pg/mL | Full Range 21.6 |
| GFF MDI 14.4/9.6 ug | AUC 0-∞ | 61.43 h*pg/mL | Full Range 12.01 |
Primary
AUC 0-∞
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞)
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GFF MDI 28.8/9.6 ug | AUC 0-∞ | 46.26 h*pg/mL |
| GFF MDI 14.4/9.6 ug | AUC 0-∞ | 32.18 h*pg/mL |
| GP MDI 28.8 ug | AUC 0-∞ | 37.32 h*pg/mL |
| GP MDI 14.4 µg | AUC 0-∞ | 34.04 h*pg/mL |
Primary
AUC 0-12
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12)
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | AUC 0-12 | 45.43 h*pg/mL | Full Range 19.43 |
| GFF MDI 14.4/9.6 ug | AUC 0-12 | 21.75 h*pg/mL | Full Range 9 |
| GP MDI 28.8 ug | AUC 0-12 | 50.59 h*pg/mL | Full Range 10.75 |
| GP MDI 14.4 µg | AUC 0-12 | 24.72 h*pg/mL | — |
Primary
AUC 0-12
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | AUC 0-12 | 44.15 h*pg/mL | Full Range 15.3 |
| GFF MDI 14.4/9.6 ug | AUC 0-12 | 42.54 h*pg/mL | Full Range 12.04 |
Primary
AUC 0-t
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | AUC 0-t | 45.96 h*pg/mL | Full Range 19.85 |
| GFF MDI 14.4/9.6 ug | AUC 0-t | 42.39 h*pg/mL | Full Range 14.69 |
Primary
AUC 0-t
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t)
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | AUC 0-t | 53.52 h*pg/mL | Full Range 3.31 |
| GFF MDI 14.4/9.6 ug | AUC 0-t | 21.37 h*pg/mL | Full Range 14.53 |
| GP MDI 28.8 ug | AUC 0-t | 64.05 h*pg/mL | Full Range 17.61 |
| GP MDI 14.4 µg | AUC 0-t | 23.72 h*pg/mL | — |
Primary
CL/F
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GFF MDI 28.8/9.6 ug | CL/F | 657.91 L/h |
| GFF MDI 14.4/9.6 ug | CL/F | 449.10 L/h |
| GP MDI 28.8 ug | CL/F | 785.60 L/h |
| GP MDI 14.4 µg | CL/F | 423.12 L/h |
Primary
CL/F
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | CL/F | 168.95 L/h | Full Range 45.28 |
| GFF MDI 14.4/9.6 ug | CL/F | 161.55 L/h | Full Range 30.17 |
Primary
Cmax
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Cmax | 15.23 pg/mL | Full Range 7.69 |
| GFF MDI 14.4/9.6 ug | Cmax | 9.09 pg/mL | Full Range 6.5 |
| GP MDI 28.8 ug | Cmax | 16.85 pg/mL | Full Range 4.26 |
| GP MDI 14.4 µg | Cmax | 7.26 pg/mL | — |
Primary
Cmax
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Cmax | 10.74 pg/mL | Full Range 3.46 |
| GFF MDI 14.4/9.6 ug | Cmax | 11.99 pg/mL | Full Range 7.07 |
Primary
Lambda z
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Lambda z | 0.1506 1/h | Full Range 7.69 |
| GFF MDI 14.4/9.6 ug | Lambda z | 0.1983 1/h | Full Range 6.5 |
| GP MDI 28.8 ug | Lambda z | 0.1100 1/h | Full Range 4.26 |
| GP MDI 14.4 µg | Lambda z | 0.1614 1/h | — |
Primary
Lambda z
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Lambda z | 0.1412 1/h | Full Range 0.0381 |
| GFF MDI 14.4/9.6 ug | Lambda z | 0.1470 1/h | Full Range 0.041 |
Primary
T 1/2
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | T 1/2 | 5.45 h | Full Range 2.39 |
| GFF MDI 14.4/9.6 ug | T 1/2 | 5.25 h | Full Range 2.32 |
Primary
T 1/2
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2)
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | T 1/2 | 9.49 h | Full Range 11.98 |
| GFF MDI 14.4/9.6 ug | T 1/2 | 4.14 h | Full Range 1.4 |
| GP MDI 28.8 ug | T 1/2 | 24.87 h | Full Range 51.77 |
| GP MDI 14.4 µg | T 1/2 | 19.13 h | — |
Primary
Tmax
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)
Time frame: Day 1
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GFF MDI 28.8/9.6 ug | Tmax | 0.10 h |
| GFF MDI 14.4/9.6 ug | Tmax | 0.10 h |
Primary
Tmax
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax)
Time frame: Day 1
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GFF MDI 28.8/9.6 ug | Tmax | 0.10 h |
| GFF MDI 14.4/9.6 ug | Tmax | 0.10 h |
| GP MDI 28.8 ug | Tmax | 0.10 h |
| GP MDI 14.4 µg | Tmax | 0.10 h |
Primary
Vd/F
Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Vd/F | 1187.75 L | Full Range 313.2 |
| GFF MDI 14.4/9.6 ug | Vd/F | 1054.16 L | Full Range 225.15 |
Primary
Vd/F
Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment
Time frame: Day 1
Population: Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GFF MDI 28.8/9.6 ug | Vd/F | 3508.00 L |
| GFF MDI 14.4/9.6 ug | Vd/F | 2577.78 L |
| GP MDI 28.8 ug | Vd/F | 3555.88 L |
| GP MDI 14.4 µg | Vd/F | 2101.03 L |
Secondary
Change in Heart Rate From Pre-dose to 12 Hours Post Dose
Change in Heart Rate from Pre-dose to 12 hours Post dose
Time frame: 12 hours
Population: Safety Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in Heart Rate From Pre-dose to 12 Hours Post Dose | 11.3 Beats/Min |
| GFF MDI 14.4/9.6 ug | Change in Heart Rate From Pre-dose to 12 Hours Post Dose | 9.3 Beats/Min |
| GP MDI 28.8 ug | Change in Heart Rate From Pre-dose to 12 Hours Post Dose | 4.5 Beats/Min |
Secondary
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (eGFR)
Time frame: 12 hours
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | -4.2 mL/min/1.73m2 | Standard Deviation 13.2 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | -7.2 mL/min/1.73m2 | Standard Deviation 16.6 |
| GP MDI 28.8 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | -3.5 mL/min/1.73m2 | Standard Deviation 15.3 |
Secondary
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ferritin)
Time frame: 12 hours
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | -14.169 μg/L | Standard Deviation 13.912 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | -11.949 μg/L | Standard Deviation 12.306 |
| GP MDI 28.8 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | -11.669 μg/L | Standard Deviation 9.731 |
Secondary
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose
Time frame: 12 hours
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Albumin (g/L) | -7.1 g/L | Standard Deviation 2.9 |
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Protein (g/L) | -10.9 g/L | Standard Deviation 5.3 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Albumin (g/L) | -6.9 g/L | Standard Deviation 4.1 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Protein (g/L) | -10.8 g/L | Standard Deviation 6.7 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
Secondary
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose
Time frame: 12 hours
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Blood urea nitrogen (mmol/L) | 0.01 mmol/L | Standard Deviation 1.45 |
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Calcium (mmol/L) | -0.15 mmol/L | Standard Deviation 0.09 |
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Chloride (mmol/L) | 3.0 mmol/L | Standard Deviation 2.3 |
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Magnesium (mmol/L) | -0.05 mmol/L | Standard Deviation 0.09 |
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Phosphorus (mmol/L) | 0.135 mmol/L | Standard Deviation 0.165 |
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Sodium (mmol/L) | 0.9 mmol/L | Standard Deviation 2.1 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Sodium (mmol/L) | 0.5 mmol/L | Standard Deviation 1.3 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Blood urea nitrogen (mmol/L) | 0.34 mmol/L | Standard Deviation 1.32 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Magnesium (mmol/L) | -0.07 mmol/L | Standard Deviation 0.09 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Phosphorus (mmol/L) | 0.163 mmol/L | Standard Deviation 0.132 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Calcium (mmol/L) | -0.14 mmol/L | Standard Deviation 0.12 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Chloride (mmol/L) | 2.5 mmol/L | Standard Deviation 1.8 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Magnesium (mmol/L) | -0.04 mmol/L | Standard Deviation 0.2 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
Secondary
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose
Time frame: 12 hours
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Direct bilirubin (μmol/L) | -3.06 μmol/L | Standard Deviation 1.75 |
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Total bilirubin (μmol/L) | -8.19 μmol/L | Standard Deviation 5.68 |
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Iron (μmol/L) | -5.42524 μmol/L | Standard Deviation 8.9 |
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Creatinine (μmol/L) | 1.88 μmol/L | Standard Deviation 11.14 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Iron (μmol/L) | -2.81888 μmol/L | Standard Deviation 7.07702 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Total bilirubin (μmol/L) | -7.14 μmol/L | Standard Deviation 4.8 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Direct bilirubin (μmol/L) | -2.53 μmol/L | Standard Deviation 1.45 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Creatinine (μmol/L) | 4.92 μmol/L | Standard Deviation 15.74 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
Secondary
Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose
Time frame: 12 hours
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | ALT (IU/L) | -3.1 IU/L | Standard Deviation 4.3 |
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Alkaline phosphatase (IU/L) | -5.2 IU/L | Standard Deviation 4.3 |
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | AST (IU/L) | -4.2 IU/L | Standard Deviation 3.7 |
| GFF MDI 28.8/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Gamma glutamyl transferase (IU/L) | -2.5 IU/L | Standard Deviation 2.4 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Gamma glutamyl transferase (IU/L) | -1.6 IU/L | Standard Deviation 1.9 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | ALT (IU/L) | -1.7 IU/L | Standard Deviation 3.1 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | AST (IU/L) | -3.3 IU/L | Standard Deviation 2.6 |
| GFF MDI 14.4/9.6 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Alkaline phosphatase (IU/L) | -5.0 IU/L | Standard Deviation 5.1 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose | AST (IU/L) | -3.7 IU/L | Standard Deviation 3 |
| GP MDI 28.8 ug | 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 |
Secondary
Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose
Time frame: 12 hours
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Potassium (mmol/L) 2 hours post-dose | -0.02 mmol/L |
| GFF MDI 28.8/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Glucose (mmol/L) 12 hours post-dose | 0.10 mmol/L |
| GFF MDI 28.8/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Potassium (mmol/L) 12 hours post-dose | 0.05 mmol/L |
| GFF MDI 28.8/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Potassium (mmol/L) 30 minutes post-dose | 0.01 mmol/L |
| GFF MDI 28.8/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Glucose (mmol/L) 2 hours post-dose | 0.05 mmol/L |
| GFF MDI 28.8/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Glucose (mmol/L) 30 minutes post-dose | -0.03 mmol/L |
| GFF MDI 28.8/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Potassium (mmol/L) 4 hours post-dose | -0.01 mmol/L |
| GFF MDI 28.8/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Glucose (mmol/L) 4 hours post-dose | -0.08 mmol/L |
| GFF MDI 14.4/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Glucose (mmol/L) 4 hours post-dose | -0.24 mmol/L |
| GFF MDI 14.4/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Glucose (mmol/L) 30 minutes post-dose | -0.08 mmol/L |
| GFF MDI 14.4/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Glucose (mmol/L) 2 hours post-dose | -0.01 mmol/L |
| GFF MDI 14.4/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Glucose (mmol/L) 12 hours post-dose | 0.18 mmol/L |
| GFF MDI 14.4/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Potassium (mmol/L) 30 minutes post-dose | 0.00 mmol/L |
| GFF MDI 14.4/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Potassium (mmol/L) 2 hours post-dose | -0.07 mmol/L |
| GFF MDI 14.4/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Potassium (mmol/L) 4 hours post-dose | -0.12 mmol/L |
| GFF MDI 14.4/9.6 ug | Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose | Potassium (mmol/L) 12 hours post-dose | -0.06 mmol/L |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
Secondary
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose
Time frame: 12 Hours
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Eosinophils (10^9cells/L) | 0.044 10^9cells/L | Standard Deviation 0.048 |
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Lymphocytes (10^9cells/L) | 0.147 10^9cells/L | Standard Deviation 0.39 |
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Leukocytes (10^9cells/L) | 0.484 10^9cells/L | Standard Deviation 1.71 |
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Basophils (10^9cells/L) | 0.007 10^9cells/L | Standard Deviation 0.025 |
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Platelets (10^9cells/L) | -22.4 10^9cells/L | Standard Deviation 24.5 |
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Monocytes (10^9cells/L) | 0.065 10^9cells/L | Standard Deviation 0.084 |
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Granulocytes (10^9cells/L) | 0.222 10^9cells/L | Standard Deviation 1.436 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Leukocytes (10^9cells/L) | 0.780 10^9cells/L | Standard Deviation 1.99 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Basophils (10^9cells/L) | 0.000 10^9cells/L | Standard Deviation 0.022 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Eosinophils (10^9cells/L) | 0.033 10^9cells/L | Standard Deviation 0.068 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Granulocytes (10^9cells/L) | 0.483 10^9cells/L | Standard Deviation 1.793 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Lymphocytes (10^9cells/L) | 0.206 10^9cells/L | Standard Deviation 0.402 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Monocytes (10^9cells/L) | 0.056 10^9cells/L | Standard Deviation 0.115 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Platelets (10^9cells/L) | -14.4 10^9cells/L | Standard Deviation 16.2 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | 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 |
Secondary
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose
Time frame: 12 Hours
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Basophils/leukocytes (ratio) | -0.0001 Ratio | Standard Deviation 0.0044 |
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Eosinophils/leukocytes (ratio) | 0.0034 Ratio | Standard Deviation 0.0089 |
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Granulocytes/leukocytes (ratio) | 0.0043 Ratio | Standard Deviation 0.0688 |
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Hematocrit (ratio) | -0.040 Ratio | Standard Deviation 0.022 |
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Lymphocytes/leukocytes (ratio) | -0.0110 Ratio | Standard Deviation 0.0565 |
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Monocytes/leukocytes (ratio) | 0.0034 Ratio | Standard Deviation 0.0125 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Monocytes/leukocytes (ratio) | 0.0004 Ratio | Standard Deviation 0.0136 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Basophils/leukocytes (ratio) | -0.0013 Ratio | Standard Deviation 0.004 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Hematocrit (ratio) | -0.041 Ratio | Standard Deviation 0.03 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Lymphocytes/leukocytes (ratio) | -0.0019 Ratio | Standard Deviation 0.0662 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Eosinophils/leukocytes (ratio) | 0.0026 Ratio | Standard Deviation 0.0131 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Granulocytes/leukocytes (ratio) | 0.0003 Ratio | Standard Deviation 0.0818 |
| GP MDI 28.8 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Eosinophils/leukocytes (ratio) | 0.0046 Ratio | Standard Deviation 0.0091 |
| GP MDI 28.8 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Granulocytes/leukocytes (ratio) | -0.0010 Ratio | Standard Deviation 0.0759 |
| GP MDI 28.8 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Monocytes/leukocytes (ratio) | -0.0006 Ratio | Standard Deviation 0.0118 |
| GP MDI 28.8 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Hematocrit (ratio) | -0.043 Ratio | Standard Deviation 0.023 |
| GP MDI 28.8 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Basophils/leukocytes (ratio) | -0.0013 Ratio | Standard Deviation 0.0039 |
| GP MDI 28.8 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Lymphocytes/leukocytes (ratio) | -0.0018 Ratio | Standard Deviation 0.0616 |
Secondary
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose
Time frame: 12 Hours
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Ery. mean corpuscuar HGB (g/L) | 12.0 g/L | Standard Deviation 15.5 |
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Hemoglobin (g/L) | -8.81 g/L | Standard Deviation 7.76 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Ery. mean corpuscuar HGB (g/L) | 8.5 g/L | Standard Deviation 13.9 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Hemoglobin (g/L) | -10.61 g/L | Standard Deviation 9.1 |
| GP MDI 28.8 ug | 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 |
| GP MDI 28.8 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | Hemoglobin (g/L) | -10.38 g/L | Standard Deviation 9.1 |
Secondary
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar volume)
Time frame: 12 Hours
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | -0.9 fL | Standard Deviation 0.6 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | -0.8 fL | Standard Deviation 0.9 |
| GP MDI 28.8 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | -0.9 fL | Standard Deviation 0.8 |
Secondary
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Erythrocytes)
Time frame: 12 Hours
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | -0.391 10^12cells/L | Standard Deviation 0.242 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | -0.419 10^12cells/L | Standard Deviation 0.326 |
| GP MDI 28.8 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | -0.433 10^12cells/L | Standard Deviation 0.253 |
Secondary
Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar hemoglobin)
Time frame: 12 Hours
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | 0.78 pg/cell | Standard Deviation 1.29 |
| GFF MDI 14.4/9.6 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | 0.49 pg/cell | Standard Deviation 1.08 |
| GP MDI 28.8 ug | Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose | 0.75 pg/cell | Standard Deviation 1.22 |
Secondary
Change in PR Interval From Pre-dose to 12 Hours Post Dose
Change in PR Interval from Pre-dose to 12 hours Post dose
Time frame: 12 hours
Population: Safety Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in PR Interval From Pre-dose to 12 Hours Post Dose | -10.7 msec |
| GFF MDI 14.4/9.6 ug | Change in PR Interval From Pre-dose to 12 Hours Post Dose | -8.5 msec |
| GP MDI 28.8 ug | Change in PR Interval From Pre-dose to 12 Hours Post Dose | -7.4 msec |
Secondary
Change in QRS Axis From Pre-dose to 12 Hours Post Dose
Change in QRS axis from Pre-dose to 12 hours Post dose
Time frame: 12 hours
Population: Safety Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in QRS Axis From Pre-dose to 12 Hours Post Dose | -0.5 QRS axis |
| GFF MDI 14.4/9.6 ug | Change in QRS Axis From Pre-dose to 12 Hours Post Dose | 4.1 QRS axis |
| GP MDI 28.8 ug | Change in QRS Axis From Pre-dose to 12 Hours Post Dose | 0.0 QRS axis |
Secondary
Change in QRS Duration From Pre-dose to 12 Hours Post Dose
Change in QRS duration from Pre-dose to 12 hours Post dose
Time frame: 12 hours
Population: Safety Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in QRS Duration From Pre-dose to 12 Hours Post Dose | -3.9 msec |
| GFF MDI 14.4/9.6 ug | Change in QRS Duration From Pre-dose to 12 Hours Post Dose | -1.1 msec |
| GP MDI 28.8 ug | Change in QRS Duration From Pre-dose to 12 Hours Post Dose | -4.0 msec |
Secondary
Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose
Change in QTc Bazett Interval from Pre-dose to 12 hours Post dose
Time frame: 12 hours
Population: Safety Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose | 7.2 msec |
| GFF MDI 14.4/9.6 ug | Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose | 4.4 msec |
| GP MDI 28.8 ug | Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose | -5.8 msec |
Secondary
Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose
Change in QTc Fridericia's Interval from Pre-dose to 12 hours Post dose
Time frame: 12 hours
Population: Safety Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose | -4.8 msec |
| GFF MDI 14.4/9.6 ug | Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose | -5.4 msec |
| GP MDI 28.8 ug | Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose | -10.8 msec |
Secondary
Change in QT Interval From Pre-dose to 12 Hours Post Dose
Change in QT Interval from Pre-dose to 12 hours Post dose
Time frame: 12 hours
Population: Safety Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GFF MDI 28.8/9.6 ug | Change in QT Interval From Pre-dose to 12 Hours Post Dose | -28.5 msec |
| GFF MDI 14.4/9.6 ug | Change in QT Interval From Pre-dose to 12 Hours Post Dose | -24.8 msec |
| GP MDI 28.8 ug | Change in QT Interval From Pre-dose to 12 Hours Post Dose | -20.5 msec |