Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001337-16 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the safety, tolerability and blood concentration of AZD3839 following oral administration of single doses in healthy men and women of non-childbearing potential
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD3839 | Experimental | Oral Treatment |
|
| AZD3839 Placebo | Placebo Comparator | Oral Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3839 | Drug | Single Oral Dose |
| |
| AZD3839 Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Event as a measure of safety and tolerability of AZD3839 (Part 1) | Part 1 - AEs will be collected from admission to the study centre (Visit 2, Day-1) until the follow-up visit (Visit 3) approximately 15 days | |
| Number of Adverse Events as a measure of Safety and tolerability of AZD3839 (Part 2) | Part 2 - AEs will be collected from admission to the study centre (Visit 2, Day-1) until the follow-up visit (Visit 4) approximately 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time at which maximum concentration occurs in AZD3839 (Part 1) | pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the administration of the investigational product, as well as on Day 4 and at the follow-up visit (Visit 3) | |
| Maximum observed concentration of AZD3839 in plasma (Part 1) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr Darren Wilbraham, MBBS DCPSA | Quintiles Drug Research Unit at Guy's Hospital | Principal Investigator |
| Dr Paul Bjornsson | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C578092 | AZD3839 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Single Oral Dose |
|
| Part 1 - pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the administration of the investigational product, as well as on Day 4 and at the follow-up visit (Visit 3) |
| Time at which maximum concentration occurs in AZD3839 (Part 2) | Part 2 - at pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the Administration. May be taken at the follow-up visit (Visit 4) |
| Maximum observed concentration of AZD3839 in plasma (Part 2) | Part 2 - at pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after administration |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |