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The purpose of this study is to compare drug blood levels of multiple formulations of inhaled PUR0200 to each other and to the reference product with and without oral charcoal.
The purpose of this study is to compare 5 different formulations of PUR0200 to the reference product. All formulations will be inhaled. In 6 of the 7 study periods either PUR0200 or the reference product will be inhaled under fasting conditions without oral charcoal. In the 7th study period, half of the subjects will receive reference with oral charcoal and the other half will receive reference product without oral charcoal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PUR0217a | Experimental | PUR0200 formulation 1 |
|
| PUR0228a | Experimental | PUR0200 formulation 2 |
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| PUR0228b | Experimental | PUR0200 formulation 3 |
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| PUR0228c | Experimental | PUR0200 formulation 4 |
|
| PUR0230c | Experimental | PUR0200 formulation 5 |
|
| Reference Product 1 | Active Comparator | Reference Product formulation with active charcoal |
|
| Reference Product 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PUR0200 | Drug | PUR0200 dry powder inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess PK parameter area under the plasma concentration versus time curve (AUC) of 5 formulations of PUR0200 compared to Reference Product | 8 hours | |
| To assess PK parameter Peak Plasma Concentration (Cmax) of 5 formulations of PUR0200 compared to Reference Product | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with treatment-related adverse events | self-reported and investigator-assessed adverse events, vital signs, and laboratory safety examinations | 8 weeks |
| Comparison of PK parameters (AUC and Cmax) in subjects dosed with Reference product after ingesting charcoal and without charcoal to assess oral vs inhalation exposure of drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valentin Kirkov, MD | Tokuda Hospital | Principal Investigator |
| David Hava, PhD | Pulmatrix Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokuda Hospital | Sofia | 1407 | Bulgaria |
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| Active Comparator |
Reference Product without active charcoal |
|
| Reference Product | Drug | Dry Powder Inhalation Reference Product |
|
| 8 hours |
| Comparison of PK parameters (AUC and Cmax) in subjects dosed with Reference product in 2 separate periods to assess the intra-subject variability of inhalation exposure to Reference product | 8 hours |