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A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of PT003 in healthy Chinese adult subjects
A Phase I, Randomized, Double-Blind, Parallel Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following a Single Administration and After Chronic Administration for 7 Days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PT010 (BGF MDI) 320/14.4/9.6 µg | Experimental | PT010 Budesonide, Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg |
|
| PT010 (BGF MDI) 160/14.4/9.6 µg | Experimental | PT010 (BGF MDI) 160/14.4/9.6 µg |
|
| PT003 (GFF MDI) 14.4/9.6 µg | Experimental | PT003 (GFF MDI) 14.4/9.6 µg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PT010 (BGF MDI) 320/14.4/9.6 µg | Drug | A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) - Budesonide | Maximum plasma concentration (Cmax) of Budesonide Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Maximum Plasma Concentration (Cmax) - Budesonide | Maximum plasma concentration (Cmax) of Budesonide Day 8 | Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Maximum Plasma Concentration (Cmax) - Glycopyrronium | Maximum plasma concentration (Cmax) of Glycopyrronium Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Maximum Plasma Concentration (Cmax) - Glycopyrronium | Maximum plasma concentration (Cmax) of Glycopyrronium Day 8 | Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Maximum Plasma Concentration (Cmax) - Formoterol | Maximum plasma concentration (Cmax) of Formoterol Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Maximum Plasma Concentration (Cmax) - Formoterol | Maximum plasma concentration (Cmax) of Formoterol Day 8 | Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Exam Findings | Number of subjects with clinically significant changes in post baseline physical exam findings | Visit 4, Day 8 |
| Laboratory Tests | Number of subjects with clinically significant changes in post baseline laboratory tests |
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Inclusion Criteria:
A male subject with female partner of child bearing potential must agree to use one additional form of medically acceptable contraception
-Be in good general health as assessed at Screening and have no clinically significant abnormal labs at Screening.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul M. Dorinsky, MD | Pearl Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Shanghai | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33152467 | Derived | Huang Y, Assam PN, Feng C, Su R, Dorinsky P, Gillen M. Ethnic pharmacokinetic comparison of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) between Asian and Western healthy subjects. Pulm Pharmacol Ther. 2020 Oct;64:101976. doi: 10.1016/j.pupt.2020.101976. Epub 2020 Nov 2. | |
| 30982547 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
This study was conducted at a single site in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | PT003 (GFF MDI) 14.4/9.6 µg | PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population - all subjects who received at least 1 dose of any blinded study drug
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | PT010 (BGF MDI) 160/14.4/9.6 µg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) - Budesonide | Maximum plasma concentration (Cmax) of Budesonide Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood glucose increased | Investigations | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pearl Therapeutics, Inc. | Pearl Therapeutics, Inc. | 1-877-240-9479 | information.center@astrazeneca.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 24, 2017 | Apr 3, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | May 12, 2017 | Dec 23, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| PT010 (BGF MDI) 160/14.4/9.6 µg | Drug | A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8. |
|
|
| PT003 (GFF MDI) 14.4/9.6 µg | Drug | A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8. |
|
|
Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 1
| Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide | Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 8 | Day 8 |
| Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium | Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 1 | Day 1 |
| Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium | Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 8 | Day 8 |
| Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol | Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 1 | Day 1 |
| Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol | Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 8 | Day 8 |
| Time to Maximum Plasma Concentration (Tmax) - Budesonide | Time to maximum plasma concentration (tmax) - Budesonide Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Time to Maximum Plasma Concentration (Tmax) - Budesonide | Time to maximum plasma concentration (tmax) - Budesonide Day 8 | Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium | Time to maximum plasma concentration (tmax) - Glycopyrronium Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium | Time to maximum plasma concentration (tmax) - Glycopyrronium Day 8 | Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Time to Maximum Plasma Concentration (Tmax) - Formoterol | Time to maximum plasma concentration (tmax) - Formoterol Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Time to Maximum Plasma Concentration (Tmax) - Formoterol | Time to maximum plasma concentration (tmax) - Formoterol Day 8 | Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Budesonide | Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Budesonide Day 1 | Day 1 |
| Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Glycopyrronium | Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Glycopyrronium Day 1 | Day 1 |
| Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Formoterol | Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Formoterol Day 1 | Day 1 |
| Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Budesonide | Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Budesonide Day 1 | Day 1 |
| Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Glycopyrronium | Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Glycopyrronium Day 1 | Day 1 |
| Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Formoterol | Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Formoterol Day 1 | Day 1 |
| Elimination Half-life (t½) - Budesonide | Elimination half-life (t½) - Budesonide Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Elimination Half-life (t½) - Glycopyrronium | Elimination half-life (t½) - Glycopyrronium Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Elimination Half-life (t½) - Formoterol | Elimination half-life (t½) - Formoterol Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Apparent Total Body Clearance (CL/F) - Budesonide | Apparent total body clearance (CL/F) - Budesonide Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Apparent Total Body Clearance (CL/F) - Glycopyrronium | Apparent total body clearance (CL/F) - Glycopyrronium Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Apparent Total Body Clearance (CL/F) - Formoterol | Apparent total body clearance (CL/F) - Formoterol Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Apparent Volume of Distribution (Vd/F) - Budesonide | Apparent volume of distribution (Vd/F) - Budesonide - Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Apparent Volume of Distribution (Vd/F) - Glycopyrronium | Apparent volume of distribution (Vd/F) - Glycopyrronium - Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Apparent Volume of Distribution (Vd/F) - Formoterol | Apparent volume of distribution (Vd/F) - Formoterol - Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Terminal Elimination Rate Constant (λz) - Budesonide | Terminal elimination rate constant (λz) - Budesonide - Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Terminal Elimination Rate Constant (λz) - Glycopyrronium | Terminal elimination rate constant (λz) - Glycopyrronium - Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Terminal Elimination Rate Constant (λz) - Formoterol | Terminal elimination rate constant (λz) - Formoterol - Day 1 | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
| Accumulation Ratio for Cmax (RAC [Cmax]) - Budesonide | Accumulation ratio for Cmax (RAC [Cmax]) - Budesonide | 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-dose |
| Accumulation Ratio for Cmax (RAC [Cmax]) - Glycopyrronium | Accumulation ratio for Cmax (RAC [Cmax]) - Glycopyrronium | 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-dose |
| Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol | Accumulation ratio for Cmax (RAC [Cmax]) - Formoterol | Day 1 and Day 8 |
| Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide | Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide | Day 1 and Day 8 |
| Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium | Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium | Day 1 and Day 8 |
| Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol | Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol | Day 1 and Day 8 |
| Visit 4, Day 8 |
| Electrocardiogram | Number of subjects with clinically significant changes in post baseline electrocardiogram | Visit 4, Day 8 |
| Serious Adverse Events/Adverse Events | Number of subjects with clinically significant changes in post baseline serious TEAEs (treatment-emergent adverse events) or TEAEs leading to withdrawal | Visit 4, Day 8 |
| Vital Signs | Number of subjects with clinically significant changes in post baseline vital signs | Visit 4, Day 8 |
| Chen Q, Hu C, Yu H, Shen K, Assam PN, Gillen M, Liu Y, Dorinsky P. Pharmacokinetics and Tolerability of Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate and Glycopyrronium/Formoterol Fumarate Dihydrate Metered Dose Inhalers in Healthy Chinese Adults: A Randomized, Double-blind, Parallel-group Study. Clin Ther. 2019 May;41(5):897-909.e1. doi: 10.1016/j.clinthera.2019.03.007. Epub 2019 Apr 11. |
| Related Info | View source |
PT010 Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 160/14.4/9.6 µg
| BG002 | PT003 (GFF MDI) 14.4/9.6 µg | PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg |
| BG003 | Total | Total of all reporting groups |
| Demographics |
|
| Years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants | Participants |
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| Smoking Status | Count of Participants | Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg | Participants |
|
| BMI | Median | Standard Deviation | kg/m^2 | Participants |
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| Primary | Maximum Plasma Concentration (Cmax) - Budesonide | Maximum plasma concentration (Cmax) of Budesonide Day 8 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
|
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| Primary | Maximum Plasma Concentration (Cmax) - Glycopyrronium | Maximum plasma concentration (Cmax) of Glycopyrronium Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Maximum Plasma Concentration (Cmax) - Glycopyrronium | Maximum plasma concentration (Cmax) of Glycopyrronium Day 8 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Maximum Plasma Concentration (Cmax) - Formoterol | Maximum plasma concentration (Cmax) of Formoterol Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Maximum Plasma Concentration (Cmax) - Formoterol | Maximum plasma concentration (Cmax) of Formoterol Day 8 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide | Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
|
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| Primary | Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Budesonide | Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Budesonide Day 8 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 8 |
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| Primary | Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium | Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
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| Primary | Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Glycopyrronium | Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Glycopyrronium Day 8 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 8 |
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| Primary | Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol | Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
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| Primary | Area Under the Plasma Concentration-time Curve From 0-12 Hours (AUC 0-12) - Formoterol | Area under the plasma concentration-time curve from 0-12 hours (AUC 0-12) - Formoterol Day 8 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 8 |
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| Primary | Time to Maximum Plasma Concentration (Tmax) - Budesonide | Time to maximum plasma concentration (tmax) - Budesonide Day 1 | 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 | Posted | Median | Full Range | h | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Time to Maximum Plasma Concentration (Tmax) - Budesonide | Time to maximum plasma concentration (tmax) - Budesonide Day 8 | 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 | Posted | Median | Full Range | h | Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium | Time to maximum plasma concentration (tmax) - Glycopyrronium Day 1 | 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 | Posted | Median | Full Range | h | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium | Time to maximum plasma concentration (tmax) - Glycopyrronium Day 8 | 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 | Posted | Median | Full Range | h | Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
|
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| Primary | Time to Maximum Plasma Concentration (Tmax) - Formoterol | Time to maximum plasma concentration (tmax) - Formoterol Day 1 | 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 | Posted | Median | Full Range | h | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Time to Maximum Plasma Concentration (Tmax) - Formoterol | Time to maximum plasma concentration (tmax) - Formoterol Day 8 | 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 | Posted | Median | Full Range | h | Day 8 Pre-dose -60, and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
|
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| Primary | Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Budesonide | Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Budesonide Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
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| Primary | Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Glycopyrronium | Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Glycopyrronium Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
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| Primary | Area Under the Plasma Concentration-time Curve From 0 to the Time of the Last Measurable Plasma Concentration (AUC 0-t) - Formoterol | Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-t) - Formoterol Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
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| Primary | Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Budesonide | Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Budesonide Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
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| Primary | Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Glycopyrronium | Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Glycopyrronium Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
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| Primary | Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC 0-∞) - Formoterol | Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC 0-∞) - Formoterol Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
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| Primary | Elimination Half-life (t½) - Budesonide | Elimination half-life (t½) - Budesonide Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Elimination Half-life (t½) - Glycopyrronium | Elimination half-life (t½) - Glycopyrronium Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Elimination Half-life (t½) - Formoterol | Elimination half-life (t½) - Formoterol Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | h | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Apparent Total Body Clearance (CL/F) - Budesonide | Apparent total body clearance (CL/F) - Budesonide Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Apparent Total Body Clearance (CL/F) - Glycopyrronium | Apparent total body clearance (CL/F) - Glycopyrronium Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Apparent Total Body Clearance (CL/F) - Formoterol | Apparent total body clearance (CL/F) - Formoterol Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Apparent Volume of Distribution (Vd/F) - Budesonide | Apparent volume of distribution (Vd/F) - Budesonide - Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Apparent Volume of Distribution (Vd/F) - Glycopyrronium | Apparent volume of distribution (Vd/F) - Glycopyrronium - Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Apparent Volume of Distribution (Vd/F) - Formoterol | Apparent volume of distribution (Vd/F) - Formoterol - Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | L | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Terminal Elimination Rate Constant (λz) - Budesonide | Terminal elimination rate constant (λz) - Budesonide - Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/h | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Terminal Elimination Rate Constant (λz) - Glycopyrronium | Terminal elimination rate constant (λz) - Glycopyrronium - Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/h | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Terminal Elimination Rate Constant (λz) - Formoterol | Terminal elimination rate constant (λz) - Formoterol - Day 1 | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/h | Day 1 Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 10, 12 and 24 h post-dose |
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| Primary | Accumulation Ratio for Cmax (RAC [Cmax]) - Budesonide | Accumulation ratio for Cmax (RAC [Cmax]) - Budesonide | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | 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-dose |
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| Primary | Accumulation Ratio for Cmax (RAC [Cmax]) - Glycopyrronium | Accumulation ratio for Cmax (RAC [Cmax]) - Glycopyrronium | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | 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-dose |
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| Primary | Accumulation Ratio for Cmax (RAC [Cmax]) - Formoterol | Accumulation ratio for Cmax (RAC [Cmax]) - Formoterol | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Day 1 and Day 8 |
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| Primary | Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide | Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Budesonide | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Day 1 and Day 8 |
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| Primary | Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium | Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Glycopyrronium | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Day 1 and Day 8 |
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| Primary | Accumulation Ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol | Accumulation ratio for AUC 0-12 (RAC [AUC 0-12]) - Formoterol | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | Day 1 and Day 8 |
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| Secondary | Physical Exam Findings | Number of subjects with clinically significant changes in post baseline physical exam findings | Safety Population | Posted | Count of Participants | Participants | Visit 4, Day 8 |
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| Secondary | Laboratory Tests | Number of subjects with clinically significant changes in post baseline laboratory tests | Safety Population | Posted | Count of Participants | Participants | Visit 4, Day 8 |
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| Secondary | Electrocardiogram | Number of subjects with clinically significant changes in post baseline electrocardiogram | Safety Population | Posted | Count of Participants | Participants | Visit 4, Day 8 |
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| Secondary | Serious Adverse Events/Adverse Events | Number of subjects with clinically significant changes in post baseline serious TEAEs (treatment-emergent adverse events) or TEAEs leading to withdrawal | Safety Population | Posted | Count of Participants | Participants | Visit 4, Day 8 |
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| Secondary | Vital Signs | Number of subjects with clinically significant changes in post baseline vital signs | Safety Population | Posted | Count of Participants | Participants | Visit 4, Day 8 |
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| 0 |
| 32 |
| 0 |
| 32 |
| 14 |
| 32 |
| EG001 | 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 | 0 | 32 | 0 | 32 | 11 | 32 |
| EG002 | PT003 (GFF MDI) 14.4/9.6 µg | PT003 Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) 14.4/9.6 µg | 0 | 32 | 0 | 32 | 14 | 32 |
| Blood potassium increased | Investigations | MedDRA | Systematic Assessment |
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| Blood potassium decreased | Investigations | MedDRA | Systematic Assessment |
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| Bilirubin conjugated increased | Investigations | MedDRA | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
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| Blood glucose decreased | Investigations | MedDRA | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Sensation of foreign body | General disorders | MedDRA | Systematic Assessment |
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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.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |