Pharmacokinetics and Safety Study of PT010 in Healthy Subjects

Study Overview
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Brief Summary
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This is a single-center, Phase I, healthy adult subject study with a randomized, double blind, three period, three-treatment, cross-over design.

Official Title
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A Phase I, Randomized, Double-Blind, Single-Dose, Three-Period, Three-Treatment, Cross-Over Study Evaluating the Pharmacokinetics and Safety of a Single Dose of PT010, a Single Dose of PT009, and a Single Dose of Open-Label Symbicort® Turbohaler® in Healthy Subjects

Conditions
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COPD

Intervention / Treatment
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* Drug: PT010
* Drug: PT009
* Drug: Symbicort Turbohaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent Form (ICF) prior to any study related procedures Male and female subjects 18 to 55 years, inclusive Good general health Medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential Clinical labs within normal ranges or determined to be not clinically significant by the Investigator Exclusion Criteria: Pregnancy, nursing female subjects, or subjects trying to conceive Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study History of ECG abnormalities Cancer not in complete remission for at least 5 years Clinically significant, symptomatic prostatic hypertrophy Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening Clinically significant bladder neck obstruction or urinary retention Inadequately treated glaucoma History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study Subjects with pre-existing anemia and/or iron deficiency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PT010<br>PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations | Drug: PT009<br>* PT009 administered as 2 inhalations<br>* Other names: PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations;Drug: Symbicort Turbohaler<br>* Symbicort Turbohaler taken as 2 inhalations<br>* Other names: Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder;|
| Experimental: PT009<br>PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations | Drug: PT010<br>* PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations<br>* Other names: PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol;Drug: Symbicort Turbohaler<br>* Symbicort Turbohaler taken as 2 inhalations<br>* Other names: Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder;|
| Active Comparator: Symbicort Turbohaler<br>Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations | Drug: PT010<br>* PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations<br>* Other names: PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol;Drug: PT009<br>* PT009 administered as 2 inhalations<br>* Other names: PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Safety of PT010, PT009 and Symbicort Turbohaler | The safety of PT010 and PT009 and Symbicort Turbohaler will be assessed based on physical examination, adverse events, vital signs, clinical laboratory values, and electrocardiogram | 12 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ◦Maximum plasma concentration (Cmax) of PT010, PT009 and Symbicort Turbohaler |  | 12 Hour post dose | 
| ◦Area under the curve from 0 to 12 hours (AUC0 12) of PT010, PT009 and Symbicort Turbohaler |  | 12 Hour post dose | 
| ◦Area under the curve from 0 to the time of the last measureable plasma concentration (AUC0 t) of PT010, PT009 and Symbicort Turbohaler |  | 12 Hour post dose | 
| ◦Area under the curve from 0 extrapolated to infinity (AUC0-∞) of PT010, PT009, and Symbicort Turbohaler |  | 12 Hour post dose | 
| ◦Time to maximum plasma concentration (tmax) of PT010, PT009, and Symbicort Turbohaler |  | 12 Hour post dose | 
| ◦Apparent terminal elimination half life (t½) of PT010, PT009, and Symbicort Turbohaler |  | 12 Hour post dose | 
| ◦Apparent total body clearance (CL/F) of PT010, PT009, and Symbicort Turbohaler |  | 12 Hour post dose | 
| ◦Apparent volume of distribution (Vd/F) of PT010, PT009, and Symbicort Turbohaler |  | 12 Hour post dose | 
| ◦Termination elimination rate constant (λz) of PT010, PT009, and Symbicort Turbohaler |  | 12 Hour post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers