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The purpose of this study is to evaluate the safety of a single dose of PT003 compared with single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two separate single doses in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Inhaled PT001 18 μg |
|
| 2 | Experimental | Inhaled PT005 2.4 μg |
|
| 3 | Experimental | Inhaled PT003 (PT001 18 μg / 2.4 μg PT005) |
|
| 4 | Experimental | PT001 18 μg + PT005 2.4 μg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PT001 | Drug | Inhaled PT001, single dose |
| |
| PT005 |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of Dry Mouth | Number of participants reporting dry mouth at 12 hours post-dose | 12 hours |
| Symptoms of Tremor | Number of participants reporting tremor at 12 hours post-dose | 12 hours |
| Blood Chemistry Change From Baseline | Series of 11 blood chemistries assessed throughout the study | 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects |
| Hematology Change From Baseline | Hematology assessments taken throughout the study Hematocrit | 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects |
| Hematology Change From Baseline | Hematology assessments taken throughout the study | 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects |
| Hematology Change From Baseline | Hematology assessments taken throughout the study Hemoglobin | 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects |
| Heart Rate Change From Baseline | Change from baseline for heart rate 12-hours post-dose Heart rate (bpm) | 12 hours |
| Vital Sign Change Baseline; Blood Pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Glycopyrrolate PK Parameters | Various pharmacokinetic parameters for plasma glycopyrrolate | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
| Plasma Glycopyrrolate PK Parameters AUC0-inf (h*pg/mL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Colin Reisner, M.D. | Pearl Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Joanne Marjason | Herston | Queensland | 4006 | Australia |
Study evaluating a single administration of inhaled treatment (PT001, PT003, PT005 and PT001+PT005 delivered from separate inhalers as a loose combination).Each subject was randomized to 1 of 4 sequences. Each sequence included the four treatment groups.
Conducted at a single site in Australia from May 2009 through July 2009. Study participation was a maximum of 7 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | All patients randomized |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Any treatment arm |
| 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 | Symptoms of Dry Mouth | Number of participants reporting dry mouth at 12 hours post-dose | All subjects in the Safety Population | Posted | Number | Participants | 12 hours |
|
Adverse events and serious adverse events were collected from the time the subject signed consent until final visit or discontinuation visit.
Safety population included all participants who received investigational drug; participants were included in safety population according to the investigational drug they were receiving at the time of the event.
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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 | Placebo + PT001 | Placebo + Glycopyrrolate MDI 72 µg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colin Reisner, MD, FCCP, FAAAAI | Pearl Therapeutics Inc. | 605-305-2600 | creisner@pearltherapeutics.com |
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| Drug |
Inhaled PT005, single dose |
|
| PT003 | Drug | Inhaled PT003, single dose |
|
| PT001 + PT005 | Drug | Inhaled PT001 + PT005, single dose |
|
Vital sign change baseline; blood pressure |
| 12 hours |
| Vital Sign Change From Baseline, SpO2 | Vital Sign Change from baseline 12-hours post-dose SpO2 (%) | 12 hours |
| ECG Change From Baseline | Change from baseline for ECG parameters 12-hours post-dose Ventricular rate (bpm) | 12 hours |
| ECG Change From Baseline | Change from baseline for ECG parameters 12-hours post-dose | 12 hours |
| Spirometry Change From Baseline | Change from baseline for spirometery measures 12-hours post-dose | 12 hours |
| Spirometry Change From Baseline | Change from baseline for spirometery measures 12-hours post-dose (FEV1 % predicted) | 12 hours |
| Spirometry Change From Baseline | Change from baseline for spirometery measures 12-hours post-dose FEV/FVC (%) | 12 hours |
| Spirometry Change From Baseline | Change from baseline for spirometery measures 12-hours post-dose PEFR (L/min) | 12 hours |
| Serum Potassium Change From Baseline | 12 hours |
Various pharmacokinetic parameters for plasma glycopyrrolate |
| Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
| Plasma Glycopyrrolate PK Parameters (Tmax) | Various pharmacokinetic parameters for plasma glycopyrrolate | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
| Plasma Glycopyrrolate PK Parameters (t1/2) | Various pharmacokinetic parameters for plasma glycopyrrolate | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
| Plasma Glycopyrrolate PK Parameters Cmax (pg/mL) | Various pharmacokinetic parameters for plasma glycopyrrolate | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
| Plasma Glycopyrrolate PK Parameters (ke) | Various pharmacokinetic parameters for plasma glycopyrrolate | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
| Plasma Formoterol PK Parameters | Various pharmacokinetic parameters for plasma formoterol | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
| Plasma Formoterol PK Parameters AUC0-inf (h*pg/mL) | Various pharmacokinetic parameters for plasma formoterol | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
| Plasma Formoterol PK Parameters (Tmax) | Various pharmacokinetic parameters for plasma formoterol | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
| Plasma Formoterol PK Parameters (t1/2) | Various pharmacokinetic parameters for plasma formoterol | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
| Plasma Formoterol PK Parameters (Cmax) | Pharmacokinetic parameters for plasma formoterol Cmax | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
| Plasma Formoterol PK Parameters (ke) | Pharmacokinetic parameters for plasma formoterol ke | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG003 | Placebo + PT003 | Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg |
|
|
| Primary | Symptoms of Tremor | Number of participants reporting tremor at 12 hours post-dose | All subjects in the Safety Population | Posted | Number | Participants | 12 hours |
|
|
|
| Primary | Blood Chemistry Change From Baseline | Series of 11 blood chemistries assessed throughout the study | All patients in the Safety Population that had a valid measurement for the parameter | Posted | Mean | Full Range | mmol/L | 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects |
|
|
|
| Primary | Blood Chemistry Change From Baseline | Series of 11 blood chemistries assessed throughout the study | All subjects in the Safety Population that had a valid measurement for the parameter | Posted | Mean | Full Range | µmol/L | 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects |
|
|
|
| Primary | Blood Chemistry Change From Baseline | Series of 11 blood chemistries assessed throughout the study | All patients in the Safety Population that had a valid measurement for the parameter | Posted | Mean | Full Range | U/L | 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects |
|
|
|
| Primary | Hematology Change From Baseline | Hematology assessments taken throughout the study Hematocrit | All subjects in the Safety Population that had a valid measurement for the parameter | Posted | Mean | Full Range | % of Red Blood Cells in the blood | 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects |
|
|
|
| Primary | Hematology Change From Baseline | Hematology assessments taken throughout the study | All subjects in the Safety Population that had a valid measurement for the parameter | Posted | Mean | Full Range | (10^9 cells/L) | 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects |
|
|
|
| Primary | Hematology Change From Baseline | Hematology assessments taken throughout the study Hemoglobin | All subjects in the Safety Population that had a valid measurement for the parameter | Posted | Mean | Full Range | g/L | 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects |
|
|
|
| Primary | Heart Rate Change From Baseline | Change from baseline for heart rate 12-hours post-dose Heart rate (bpm) | All subjects in the Safety Population that had a valid measurement for the parameter | Posted | Mean | Full Range | bpm | 12 hours |
|
|
|
| Primary | Vital Sign Change Baseline; Blood Pressure | Vital sign change baseline; blood pressure | All subjects in the Safety Population that had a valid measurement for the parameter | Posted | Mean | Full Range | mmHg | 12 hours |
|
|
|
| Primary | Vital Sign Change From Baseline, SpO2 | Vital Sign Change from baseline 12-hours post-dose SpO2 (%) | All subjects in the Safety Population that had a valid measurement for the parameter | Posted | Mean | Full Range | % blood oxygen saturation level | 12 hours |
|
|
|
| Primary | ECG Change From Baseline | Change from baseline for ECG parameters 12-hours post-dose Ventricular rate (bpm) | Safety population | Posted | Mean | Full Range | bpm | 12 hours |
|
|
|
| Primary | ECG Change From Baseline | Change from baseline for ECG parameters 12-hours post-dose | Safety population | Posted | Mean | Full Range | ms | 12 hours |
|
|
|
| Primary | Spirometry Change From Baseline | Change from baseline for spirometery measures 12-hours post-dose | Safety population | Posted | Mean | Full Range | Liters | 12 hours |
|
|
|
| Primary | Spirometry Change From Baseline | Change from baseline for spirometery measures 12-hours post-dose (FEV1 % predicted) | Safety population | Posted | Mean | Full Range | % predicted | 12 hours |
|
|
|
| Primary | Spirometry Change From Baseline | Change from baseline for spirometery measures 12-hours post-dose FEV/FVC (%) | Safety population | Posted | Mean | Full Range | Ratio | 12 hours |
|
|
|
| Primary | Spirometry Change From Baseline | Change from baseline for spirometery measures 12-hours post-dose PEFR (L/min) | Safety population | Posted | Mean | Full Range | L/min | 12 hours |
|
|
|
| Secondary | Plasma Glycopyrrolate PK Parameters | Various pharmacokinetic parameters for plasma glycopyrrolate | Subjects with an evaluable profile for this analyte | Posted | Mean | Standard Deviation | h*pg/mL | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
|
|
|
| Secondary | Plasma Glycopyrrolate PK Parameters AUC0-inf (h*pg/mL) | Various pharmacokinetic parameters for plasma glycopyrrolate | Subjects with an evaluable profile for this analyte | Posted | Mean | Standard Deviation | h*pg/mL | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
|
|
|
| Secondary | Plasma Glycopyrrolate PK Parameters (Tmax) | Various pharmacokinetic parameters for plasma glycopyrrolate | Subjects with an evaluable profile for this analyte | Posted | Mean | Standard Deviation | h | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
|
|
|
| Secondary | Plasma Glycopyrrolate PK Parameters (t1/2) | Various pharmacokinetic parameters for plasma glycopyrrolate | Subjects with an evaluable profile for this analyte | Posted | Mean | Standard Deviation | h | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
|
|
|
| Secondary | Plasma Glycopyrrolate PK Parameters Cmax (pg/mL) | Various pharmacokinetic parameters for plasma glycopyrrolate | Subjects with an evaluable profile for this analyte | Posted | Mean | Standard Deviation | pg/mL | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
|
|
|
| Secondary | Plasma Glycopyrrolate PK Parameters (ke) | Various pharmacokinetic parameters for plasma glycopyrrolate | Subjects with an evaluable profile for this analyte | Posted | Mean | Standard Deviation | 1/h | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
|
|
|
| Secondary | Plasma Formoterol PK Parameters | Various pharmacokinetic parameters for plasma formoterol | Subjects with an evaluable profile for this analyte | Posted | Mean | Standard Deviation | h*pg/mL | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
|
|
|
| Secondary | Plasma Formoterol PK Parameters AUC0-inf (h*pg/mL) | Various pharmacokinetic parameters for plasma formoterol | Subjects with an evaluable profile for this analyte | Posted | Mean | Standard Deviation | h*pg/mL | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
|
|
|
| Secondary | Plasma Formoterol PK Parameters (Tmax) | Various pharmacokinetic parameters for plasma formoterol | Subjects with an evaluable profile for this analyte | Posted | Mean | Standard Deviation | h | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
|
|
|
| Secondary | Plasma Formoterol PK Parameters (t1/2) | Various pharmacokinetic parameters for plasma formoterol | Subjects with an evaluable profile for this analyte | Posted | Mean | Standard Deviation | h | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
|
|
|
| Secondary | Plasma Formoterol PK Parameters (Cmax) | Pharmacokinetic parameters for plasma formoterol Cmax | Subjects with an evaluable profile for this analyte | Posted | Mean | Standard Deviation | pg/mL | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
|
|
|
| Secondary | Plasma Formoterol PK Parameters (ke) | Pharmacokinetic parameters for plasma formoterol ke | Subjects with an evaluable profile for this analyte | Posted | Mean | Standard Deviation | 1/h | Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose |
|
|
|
| Primary | Serum Potassium Change From Baseline | All subjects in the Safety Population | Posted | Median | Full Range | mmol/L | 12 hours |
|
|
|
| 0 |
| 15 |
| 7 |
| 15 |
| EG001 | Placebo + PT005 | Placebo + Formoterol Fumarate 9.6 µg | 0 | 13 | 6 | 13 |
| EG002 | PT001 + PT005 | Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order) | 0 | 16 | 8 | 16 |
| EG003 | Placebo + PT003 | Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg | 0 | 15 | 9 | 15 |
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
| 30-minutes post-dose |
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| 1-hour post-dose |
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| 2-hours post-dose |
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| 4-hours post-dose |
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| 6-hours post-dose |
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| 8-hours post-dose |
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| 12-hours post-dose |
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| Chloride |
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| Urea |
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| Calcium |
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| Bicarbonate |
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| Glucose |
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| Bilirubin |
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| ALT |
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| AST |
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| Platelets |
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| Diastolic blood pressure (mmHg) |
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| QRS duration (ms) |
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| QT interval (ms) |
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| QTcB (ms) |
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| QTcF (ms) |
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| FVC (L) |
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| AUC0-12 (h*pg/mL) |
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| AUC0-12 (h*pg/mL) |
|