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This is a single dose study in healthy male and female (of non-child bearing potential) volunteers, to assess the safety, effects on the body, and blood and urine drug levels of AZD3293. AZD3293 is being developed for the treatment of Alzheimer's Disease
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 Including an Open-Label Food Effect Group in Healthy Male and Non-Fertile Female Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD3293 | Experimental | Up to 11 sequential cohorts of healthy young and healthy elderly subjects are planned, with single ascending doses ranging from 1mg to a maximum of 1000mg |
|
| Placebo | Placebo Comparator | Placebo given (2 subjects in each cohort) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3293 | Drug | Oral solution |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event monitoring. | From baseline up to 10 days. | |
| Assessment of vital signs and physical examination. | The vital signs of body temperature, blood pressure and pulse are going to be measured. | From baseline up to 10 days. |
| Clinical laboratory tests: hematology. | From baseline up to 10 days. | |
| Clinical laboratory tests: urine analysis. | From baseline up to 10 days. | |
| Evaluation of 12-lead digital electrocardiogram (ECG). | QT/QTc interval, rhythm, rate, morphology is going to be measured. | From baseline up to 10 days. |
| Assessment of telemetry. | As reported by investigator. | From baseline up to 10 days. |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Columbia-Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). Completed suicide and non-fatal suicide events are yes/no questions and results presented are the number of participants with these events. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline. | From baseline up to 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) in the terms of AUC, AUC(0-t), AUC(0-24). | Where (AUC(0-t)) is area under the plasma concentration-time curve from zero to the last measurable concentration and (AUC(0-24)) area under the plasma concentration-time curve from zero to 24 hours post-dose. | Up 4 days |
| Investigation on the effect of AZD3293 on biomarkers relevant for Pharmacodynamics in plasma. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert C Alexander, MD | AstraZeneca | Study Director |
| Ronald Goldwater, MD | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baltimore | Maryland | United States |
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| ID | Term |
|---|---|
| C000608388 | lanabecestat |
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| Drug |
Oral solution |
|
Biomarker PD Aβ (1-40, 1-42) parameters are:
|
| Up to 4 days. |
| Investigation of the potential influence of food on Pharmacokinetics (PK) following a single dose of AZD3293. | Pharmacokinetics (PK) in the terms of plasma Cmax and AUC. | Up to 4 days. |
| Investigation of the relationship between Pharmacokinetics (PK) and Pharmacodynamics (PD) of AZD3293. | The Pharmacokinetics (PK) variables may be plasma concentrations or summary measurements such as Cmax or AUC. The Pharmacodynamics (PD) variables may include biomarkers in plasma such as Aβ (1-40, 1-42) or exploratory PD biomarkers, or safety variables. | Up to 4 days. |
| Pharmacokinetics assessment in the terms of fu (%) (fraction of unbound AZD3293 and AZ13569724 in plasma). | Up to 4 days. |
| Pharmacokinetics in the terms of Cmax (Maximum observed plasma concentration) and tmax (Time to Cmax ). | Up to 4 days. |