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Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010
A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With and Without Oral Charcoal
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Period 1 | Experimental | Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C) |
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| Treatment Period 2 | Experimental | Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C) |
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| Treatment Period 3 | Experimental | Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C) |
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| Treatment Period 4 | Experimental | Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regimen A | Drug | 2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax)-Budesonide | Maximum plasma concentration (Cmax) per Regimen | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
| Maximum Plasma Concentration (Cmax)-Glycopyrronium | Maximum plasma concentration (Cmax) per Regimen | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
| Maximum Plasma Concentration (Cmax)-Formoterol | Maximum plasma concentration (Cmax) per Regimen | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
| Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Budesonide | Each treatment period is equal to assigned regimen | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
| Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Glycopyrronium | Each treatment period is equal to assigned regimen | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
| Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Formoterol | Each treatment period is equal to assigned regimen | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Plasma Concentration (Tmax)-Budesonide | Each treatment period is equal to assigned regimen | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h 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 |
|---|---|---|---|---|---|---|
| Pearl Investigative Site | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32253054 | Derived | Dorinsky P, DePetrillo P, DeAngelis K, Trivedi R, Darken P, Gillen M. Relative Bioavailability of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Administered With and Without a Spacer: Results of a Phase I, Randomized, Crossover Trial in Healthy Adults. Clin Ther. 2020 Apr;42(4):634-648. doi: 10.1016/j.clinthera.2020.02.012. Epub 2020 Apr 3. |
| Label | URL |
|---|---|
| Related Info | View source |
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Elig subj. received single dose of BGF MDI (Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler) 320/28.8/9.6 μg as:
Regimen A: BGF MDI w/out spacer, w/out charcoal Regimen B: BGF MDI with spacer, w/out charcoal Regimen C: BGF MDI w/out spacer, with charcoal Regimen D: BGF MDI with spacer, with charcoal
This study was conducted at a single center in the United States from November 2017 to December 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Regimens | BGF MDI 320/28.8/9.6 μg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jan 16, 2018 | Mar 27, 2020 |
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| Regimen B | Drug | 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure |
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| Regimen C | Drug | 2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure |
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| Regimen D | Drug | 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure |
|
Each treatment period is equal to assigned regimen
| Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
| Time to Maximum Plasma Concentration (Tmax)-Formoterol | Each treatment period is equal to assigned regimen | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
| Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Budesonide | Each treatment period is equal to assigned regimen | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
| Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Glycopyrronium | Each treatment period is equal to assigned regimen | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
| Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Formoterol | Each treatment period is equal to assigned regimen | 24 hrs |
| Related Info | View source |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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) per Regimen | PK Population: All subjects in the Safety Population for whom at least one of the primary PK parameters for a given analyte could be calculated and who had no important protocol deviations thought to impact the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
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| Primary | Maximum Plasma Concentration (Cmax)-Glycopyrronium | Maximum plasma concentration (Cmax) per Regimen | PK Population: All subjects in the Safety Population for whom at least one of the primary PK parameters for a given analyte could be calculated and who had no important protocol deviations thought to impact the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Maximum Plasma Concentration (Cmax)-Formoterol | Maximum plasma concentration (Cmax) per Regimen | PK Population: All subjects in the Safety Population for whom at least one of the primary PK parameters for a given analyte could be calculated and who had no important protocol deviations thought to impact the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
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| Primary | Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Budesonide | Each treatment period is equal to assigned regimen | PK Population: All subjects in the Safety Population for whom at least one of the primary PK parameters for a given analyte could be calculated and who had no important protocol deviations thought to impact the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
| ||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Glycopyrronium | Each treatment period is equal to assigned regimen | PK Population: All subjects in the Safety Population for whom at least one of the primary PK parameters for a given analyte could be calculated and who had no important protocol deviations thought to impact the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
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| Primary | Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Formoterol | Each treatment period is equal to assigned regimen | PK Population: All subjects in the Safety Population for whom at least one of the primary PK parameters for a given analyte could be calculated and who had no important protocol deviations thought to impact the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
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| Secondary | Time to Maximum Plasma Concentration (Tmax)-Budesonide | Each treatment period is equal to assigned regimen | PK Population: All subjects in the Safety Population for whom at least one of the primary PK parameters for a given analyte could be calculated and who had no important protocol deviations thought to impact the analysis of the PK data. | Posted | Median | Full Range | h (hour) | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
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| Secondary | Time to Maximum Plasma Concentration (Tmax)-Glycopyrronium | Each treatment period is equal to assigned regimen | PK Population: All subjects in the Safety Population for whom at least one of the primary PK parameters for a given analyte could be calculated and who had no important protocol deviations thought to impact the analysis of the PK data. | Posted | Median | Full Range | h (hour) | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
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| Secondary | Time to Maximum Plasma Concentration (Tmax)-Formoterol | Each treatment period is equal to assigned regimen | PK Population: All subjects in the Safety Population for whom at least one of the primary PK parameters for a given analyte could be calculated and who had no important protocol deviations thought to impact the analysis of the PK data. | Posted | Median | Full Range | h (hour) | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
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| Secondary | Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Budesonide | Each treatment period is equal to assigned regimen | PK Population: All subjects in the Safety Population for whom at least one of the primary PK parameters for a given analyte could be calculated and who had no important protocol deviations thought to impact the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
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| Secondary | Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Glycopyrronium | Each treatment period is equal to assigned regimen | PK Population: All subjects in the Safety Population for whom at least one of the primary PK parameters for a given analyte could be calculated and who had no important protocol deviations thought to impact the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose |
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| Secondary | Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Formoterol | Each treatment period is equal to assigned regimen | PK Population: All subjects in the Safety Population for whom at least one of the primary PK parameters for a given analyte could be calculated and who had no important protocol deviations thought to impact the analysis of the PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*pg/mL | 24 hrs |
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Adverse events were collected from the time of administration of the first dose of study drug to the time of the follow-up telephone call, study termination, or study exit up to a total of approximately 12 weeks.
Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 13 weeks, which includes screening and follow up (5-7 day period after 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 | Regimen B | BGF MDI 320/28.8/9.6 μg with a spacer device and without charcoal | 0 | 53 | 0 | 53 | 4 | 53 |
| EG001 | Regimen A | BGF MDI 320/28.8/9.6 μg without spacer device and without charcoal | 0 | 52 | 0 | 52 | 1 | 52 |
| EG002 | Regimen C | BGF MDI 320/28.8/9.6 μg without a spacer device and with charcoal | 0 | 52 | 0 | 52 | 4 | 52 |
| EG003 | Regimen D | BGF MDI 320/28.8/9.6 μg with a spacer device and with charcoal | 0 | 52 | 0 | 52 | 4 | 52 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pearl Therapeutics, Inc. | Pearl Therapeutics, Inc. | 1-877-240-9479 | information.center@astrazeneca.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 11, 2017 | Mar 27, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C103940 | OOS-A regimen |
| C072254 | Regimen B |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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