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This is a randomized double-blind (investigator and subject blinded), placebo controlled ascending single dose study to evaluate the safety, tolerability, and pharmacokinetic profile of BPN14770 in healthy male and female subjects. Each subject will be randomized to receive either a single dose of BPN14770 or placebo.
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPN14770 | Experimental | A single oral dose of BPN14770. |
|
| Placebo | Placebo Comparator | A single oral dose of placebo matching BPN14770 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPN14770 | Drug | BPN14770 is an investigational new drug being developed for the treatment of Alzheimer's disease and other cognitive disorders. BPN14770 is a small molecule, subtype selective, negative allosteric modulator of phosphodiesterase 4D. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Incidence and nature of adverse events (AEs) and serious adverse events (SAEs). Significant assessments reported as AEs or SAEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead electrocardiogram (ECG) | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve from Time Zero Extrapolated to Infinity [AUC0-∞] | 48 hr | |
| Maximum Concentration [Cmax] | 48 hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Reines, MD, PhD | Tetra Discovery Partners | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jasper Clinic | Kalamazoo | Michigan | 49007 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000723101 | BPN14770 |
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| Placebo | Drug |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |