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| Name | Class |
|---|---|
| Quotient Clinical | OTHER |
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TRx0037 after multiple doses in elderly volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRx0037 | Experimental | Double blind placebo controlled study of TRx0037 in healthy elderly volunteers to assess safety, tolerability, bioavailability and pharmacokinetics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRx0037 | Drug | 75mg and 100mg tablets used to create doses of 100mg and 175mg. Active placebo 2mg and blank placebo used as comparators. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability | The bioavailability of TRx0037 in an older population closer to the typical age range of the target patient population. | 19 Days (7-10 day follow up) |
| Pharmacokinetics | The pharmacokinetics for single doses of TRx0037 in healthy elderly volunteers. | 19 Days (7-10 day follow up) |
| Safety and tolerability | Safety and tolerability measurements including adverse events, physical examination findings, vital signs, ECG, and clinical laboratory measurements for single doses of TRx0037 | 19 Days (7-10 day follow up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Dr Mair, MBChB | Quotient Clinical | Principal Investigator |
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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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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |