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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01335451 | Assess the Safety, Tolerability and Pharmacokinetics of AZD5213 After Single and Multiple Ascending Oral Doses in Healthy Young and Elderly Japanese Subjects | PHASE1 | COMPLETED | 48 | — | — | Apr 1, 2011 | Oct 1, 2011 | Jan 28, 2015 | 1 | Japan |
| NCT01171105 | Study to Investigate Multiple Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects | PHASE1 | COMPLETED | 73 | — | — | Jul 1, 2010 | May 1, 2011 | Jan 28, 2015 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | Each cohort will have 6 subjects that will receive AZD5213 |
| Placebo | PLACEBO_COMPARATOR | Each cohort will have 2 subjects that will receive placebo |
| 1 | EXPERIMENTAL | AZD5213 (dose escalating) |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| AZD5213 | DRUG | Four increasing doses for young and two increasing doses for elderly subjects. Subject will receive single dose of AZD5213 oral solution (Day 1) and then start the once daily repeated doses from Day 3 to 12 for 10 days |
| Placebo | DRUG | Placebo solution, single dose (Day 1) and repeated dose from Day 3 to 12 for 10 days |
| Placebo to AZD5213 | DRUG | - |
Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * Japanese healthy male subjects aged 20 to 45 years (young) and male and female subjects aged 65 to 80 years (elderly) * Male subjects should be willing to use barrier contraception...