Clinical Study to Evaluate the Pharmacokinetics and Safety of BDP HFA Nasal Aerosol

Study Overview
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Brief Summary
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The purpose of this study is to compare the systemic levels of beclomethasone 17 monopropionate (17 BMP - the active metabolite of BDP) after intranasal administration of BDP HFA with the systemic levels of 17 BMP after administration of orally inhaled BDP HFA in healthy volunteers.

Official Title
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A Randomized, Open-Label, 3-Period Crossover Study to Investigate the Pharmacokinetics, Safety and Tolerability of BDP HFA Nasal Aerosol in Healthy Volunteers

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: BDP HFA Nasal Aerosol
* Drug: BDP HFA Nasal Aerosol
* Drug: BDP HFA Inhalation Aerosol (QVAR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent Male or female subjects 18-45 years of age General good health Exclusion Criteria: History of physical findings of nasal pathology (within 60 days prior to Screening Visit) Participation in any investigational drug study 30 days preceding Screening Visit History of respiratory infection/disorder with 28 days preceding Screening Visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BDP HFA Nasal Aerosol 80 mcg/d<br>single dose, intranasal aerosol | Drug: BDP HFA Nasal Aerosol<br>* BDP HFA Nasal 80mcg<br>|
| Experimental: BDP HFA Nasal Aerosol 320 mcg/d<br>single dose, intranasal aerosol | Drug: BDP HFA Nasal Aerosol<br>* BDP HFA Nasal 320mcg<br>|
| Active Comparator: BDP HFA Inhalation Aerosol 320 mcg/d<br>single dose, orally inhaled aerosol | Drug: BDP HFA Inhalation Aerosol (QVAR)<br>* BDP HFA Oral 320mcg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Area under the plasma concentration time curve until the last measurable value (AUClast) for 17-BMP Maximum plasma concentration (Cmax) for 17-BMP | 24 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Area under the plasma concentration time curve extrapolated to infinity (AUC0-inf), time to mean peak plasma concentration (Tmax), and the terminal elimination half-life (t1/2) for 17-BMP AUClast, AUC0-inf, Cmax, Tmax, t1/2 for BDP | 24 hours post dose | 
| Safety and tolerability of BDP HFA nasal aerosol | Change from baseline in safety and tolerability endpoints - including Adverse events, changes in vital signs (blood pressure and pulse rate) and ENT exams (every visit) and safety laboratory assessments and physical exams (end of study) | 24 hours post dose |