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This is a Phase I open-label, single center study to assess the PK and safety of BGF MDI 320/14.4/9.6 µg in subjects with moderate to severe COPD. Pharmacokinetics will be assessed following a single dose administration on the first treatment day (Day 1) and will be assessed again after 7 days of repeat dosing. This study includes a Screening Period of up to 28 days and a single Treatment Period of 8 days. A follow-up phone call will be conducted at least 5 days but no longer than 7 days after the last dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PT010 | Experimental | PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol per protocol. Administered as 2 inhalations per use as instructed in the protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PT010 | Drug | PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations per use as instructed per the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) - Budesonide | Maximum plasma concentration (Cmax) - Budesonide | Day 1 |
| Maximum Plasma Concentration (Cmax) - Budesonide | Maximum plasma concentration (Cmax) - Budesonide | Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose |
| Maximum Plasma Concentration (Cmax) - Glycopyrronium | Maximum plasma concentration (Cmax) - Glycopyrronium | Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose) |
| Maximum Plasma Concentration (Cmax) - Glycopyrronium | Maximum plasma concentration (Cmax) - Glycopyrronium | Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose) |
| Maximum Plasma Concentration (Cmax) - Formoterol | Maximum plasma concentration (Cmax) - Formoterol | Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose) |
| Maximum Plasma Concentration (Cmax) - Formoterol | Maximum plasma concentration (Cmax) - Formoterol | Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose) |
| Area Under the Plasma Concentration-time Curve (AUC 0-12) - Budesonide | Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Budesonide | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) - Budesonide | Time to maximum plasma concentration (tmax) - Budesonide | Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose) |
| Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul M Dorinsky, MD | Pearl Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Clearwater | Florida | 33765 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31841699 | Derived | Dunn LJ, Kerwin EM, DeAngelis K, Darken P, Gillen M, Dorinsky P. Pharmacokinetics of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler formulated using co-suspension delivery technology after single and chronic dosing in patients with COPD. Pulm Pharmacol Ther. 2020 Feb;60:101873. doi: 10.1016/j.pupt.2019.101873. Epub 2019 Dec 10. |
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BGF MDI 320/14.4/9.6 μg oral inhalation as follows:
This study was conducted at a single center in the United States from August 2017 to December 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | PT010 | Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population: All subjects who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | PT010 | Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 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) - Budesonide | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Day 1 |
|
|
Adverse events were collected from the time of administration of the first dose of study drug to the time of the final follow-up telephone call up to approximately 7 weeks.
The Safety Population was defined as all subjects who receive at least 1 dose of study drug.
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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 | 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 |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2017 | Apr 24, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 18, 2017 | Apr 24, 2020 | SAP_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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|
| Area Under the Plasma Concentration-time Curve (AUC 0-12) - Budesonide | Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Budesonide | Day 8 |
| Area Under the Plasma Concentration-time Curve (AUC 0-12) - Glycopyrronium | Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Glycopyrronium | Day 1 |
| Area Under the Plasma Concentration-time Curve (AUC 0-12) - Glycopyrronium | Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Glycopyrronium | Day 8 |
| Area Under the Plasma Concentration-time Curve (AUC 0-12) - Formoterol | Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Formoterol | Day 1 |
| Area Under the Plasma Concentration-time Curve (AUC 0-12) - Formoterol | Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Formoterol | Day 8 |
| Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Budesonide | Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Budesonide | Day 1 |
| Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Glycopyrronium | Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Glycopyrronium | Day 1 |
| Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Formoterol | Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Formoterol | Day 1 |
Time to maximum plasma concentration (tmax) - Glycopyrronium |
| Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose) |
| Time to Maximum Plasma Concentration (Tmax) - Formoterol | Time to maximum plasma concentration (tmax) - Formoterol | Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose) |
| Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Budesonide | Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Budesonide | Day 1 |
| Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Glycopyrronium | Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Glycopyrronium | Day 1 |
| Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Formoterol | Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Formoterol | Day 1 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) - Budesonide | Maximum plasma concentration (Cmax) - Budesonide | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) - Glycopyrronium | Maximum plasma concentration (Cmax) - Glycopyrronium | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose) |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) - Glycopyrronium | Maximum plasma concentration (Cmax) - Glycopyrronium | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose) |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) - Formoterol | Maximum plasma concentration (Cmax) - Formoterol | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose) |
|
|
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| Primary | Maximum Plasma Concentration (Cmax) - Formoterol | Maximum plasma concentration (Cmax) - Formoterol | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose) |
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve (AUC 0-12) - Budesonide | Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Budesonide | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve (AUC 0-12) - Budesonide | Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Budesonide | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 8 |
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve (AUC 0-12) - Glycopyrronium | Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Glycopyrronium | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve (AUC 0-12) - Glycopyrronium | Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Glycopyrronium | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 8 |
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve (AUC 0-12) - Formoterol | Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Formoterol | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve (AUC 0-12) - Formoterol | Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Formoterol | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 8 |
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Budesonide | Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Budesonide | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Glycopyrronium | Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Glycopyrronium | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
|
|
|
| Primary | Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Formoterol | Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Formoterol | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
|
|
|
| Secondary | Time to Maximum Plasma Concentration (Tmax) - Budesonide | Time to maximum plasma concentration (tmax) - Budesonide | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Median | Full Range | hours | Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose) |
|
|
|
| Secondary | Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium | Time to maximum plasma concentration (tmax) - Glycopyrronium | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Median | Full Range | hours | Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose) |
|
|
|
| Secondary | Time to Maximum Plasma Concentration (Tmax) - Formoterol | Time to maximum plasma concentration (tmax) - Formoterol | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Median | Full Range | hours | Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose) |
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|
| Secondary | Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Budesonide | Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Budesonide | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Glycopyrronium | Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Glycopyrronium | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
|
|
|
| Secondary | Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Formoterol | Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Formoterol | PK Population - All treated subjects who had sufficient data to reliably calculate at least 1 PK parameter for at least one analyte and did not have major protocol deviations which affected the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Day 1 |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 5 |
| 30 |
| Restless legs syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
Drafts of any and all publications or presentations that may arise from this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review and approval and to ensure consistency with the policy in this protocol. Pearl Therapeutics will have 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.
| 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 |
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