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This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of BLU-5937 using a double blind, placebo controlled, randomized, adaptive, single center study design. The influence of food on the pharmacokinetics of BLU-5037 will also be investigated.
BLU-5937 is a selective P2X3 receptor antagonist being developed for the treatment of chronic cough. This Phase 1 study will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of BLU-5937 administered orally to healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Doses | Experimental | Single ascending doses, 6 dose levels |
|
| Multiple Ascending Doses | Experimental | Multiple ascending doses, 3 dose levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLU-5937 | Drug | BLU-5937 oral tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of treatment emergent adverse events (TEAEs) | Number and severity of TEAEs collected from dosing until follow up 48 hours after last dose | up to 48 hours after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | To assess Cmax of single and multiple ascending oral doses of BLU-5937 | up to 48 hours after the last dose |
| Area under the curve (AUC) | To assess AUC of single and multiple ascending oral doses of BLU-5937 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alta Sciences Algorithme Pharma | Mount Royal | Quebec | H3P 3P1 | Canada |
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C000657411 | BLU-5937 |
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| Placebo |
| Drug |
Matching placebo to BLU-5937 |
|
| up to 48 hours after the last dose |
| Maximum plasma concentration (Cmax) under fed conditions | To assess Cmax of a single oral dose of BLU-5937 under fed conditions | up to 48 hours after the last dose |
| Area under the curve (AUC) under fed conditions | To assess AUC of a single oral dose of BLU-5937 under fed conditions | up to 48 hours after the last dose |
| D013568 | Pathological Conditions, Signs and Symptoms |