A Safety, Pharmacokinetic and Pharmacodynamic Study of PUR0200 in COPD Patients

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and tolerability of PUR0200. In addition, the study will look at the blood levels of different doses of PUR0200 and their affect on lung function in COPD patients.

Detailed Description
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This is a multi-center, 2-part, pharmacokinetic (PK), pharmacodynamic (PD) effect, safety and tolerability study of single doses of PUR0200.

Official Title
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A Phase I, 2-Part, Single-dose, Placebo and Active-Controlled, Dose-ranging, Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: PUR0200
* Drug: PUR0200 Placebo
* Drug: Active comparator


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: A clinical diagnosis of moderate to severe COPD according to the following criteria: Current or ex-smokers with at least 10 pack-year smoking history Post-bronchodilator FEV1 >/= 35% and </= 80% of predicted normal value Post-bronchodilator FEV1/FVC (forced vital capacity) ratio <0.70 Post-bronchodilator improvement in FEV1 >/= 100 mL Key Exclusion Criteria: Current evidence or recent history of clinically significant or unstable disease (other than COPD) Current diagnosis of asthma Presence of history of clinically significant allergy requiring treatment COPD exacerbation within 6 weeks Use of daily oxygen therapy > 10 hours Thoracotomy with pulmonary resection Use of systemic steroids within 3 months Lower respiratory tract infection within 30 days Upper respiratory tract infection within 30 days requiring treatment with antibiotics History of tuberculosis, bronchiectasis, or other non-specific pulmonary disease Prolonged corrected QT (QTc) interval >450 msec males and >470 msec females, or history of long QT syndrome

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: PUR0200 low dose<br>PUR0200 low dose, single dose inhalation | Drug: PUR0200<br>* Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator<br>|
| Experimental: PUR0200 mid dose<br>PUR0200 mid dose, single dose inhalation | Drug: PUR0200<br>* Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator<br>|
| Experimental: PUR0200 high dose<br>PUR0200 high dose, single dose inhalation | Drug: PUR0200<br>* Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator<br>|
| Placebo Comparator: Placebo<br>PUR0200 matched placebo, single dose, inhalation | Drug: PUR0200 Placebo<br>* Randomized, single dose of inhaled placebo matched to PUR0200<br>|
| Active Comparator: Active Comparator<br>Active Comparator, single dose, inhalation | Drug: Active comparator<br>* Randomized single dose of inhaled active comparator product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) of PUR0200 |  | 0 to 24 hours | 
| Time to reach peak plasma (Tmax) concentration of PUR0200 |  | 0 to 24 hours | 
| Area under the plasma concentration versus time (AUC) of PUR0200 |  | 0 to 24 hours | 
| Trough forced expiratory volume in 1 second (FEV1) |  | 24 hours | 
| Trough FEV1 difference from baseline |  | 24 hours | 
| Number of participants with adverse events | adverse events, vital signs, clinical laboratory changes, and ECG changes will be evaluated | up to 14 days post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Chronic Obstructive Pulmonary Disease