Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02005211 | A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers | PHASE1 | COMPLETED | 114 | — | — | Dec 1, 2013 | Jul 1, 2014 | Nov 4, 2016 | 1 | Japan |
Safety - Number of subjects reporting any adverse events during the study
| Arm | Type | Description |
|---|---|---|
| AZD3293 | EXPERIMENTAL | AZD3293 will be administered as single dose of an oral solution in Part 1 and single and multiple doses of an oral solution in Part 2. The ascending doses are planned to be 15, 50 and 150 mg for young subjects in Part 1 and 15 and 50 mg for elderly subjects in Part 2. Before proceeding to next dose level, safety, tolerability and pharmacokinetic data from the previous cohort(s) will be evaluated by a Safety Review Committee. Part 2 will start after confirming safety and tolerability in Part 1. |
| Placebo | PLACEBO_COMPARATOR | Placebo given (2 subjects in each cohort) |
| Name | Type | Description |
|---|---|---|
| AZD3293 | DRUG | Oral solution |
| Placebo | DRUG | Oral solution |
Inclusion Criteria: * Healthy Japanese elderly and young males and females (of non-childbearing potential) * Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 40 kg and no more than 100 kg Exclusion Criteria: * Psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psyc...