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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00818129 | Study to Investigate Safety, Tolerability and PK Following Single and Multiple Ascending Doses of AZD7295 in Japanese | PHASE1 | COMPLETED | 62 | — | — | Dec 1, 2008 | May 1, 2009 | Jul 23, 2009 | 1 | Japan |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AZD7295 | DRUG | ascending single doses (start dose 90 mg), oral solution and then multiple ascending dose (tbd based on single dose results), oral solution |
| Placebo | DRUG | multiple ascending dose (tbd based on single dose results), oral solution |
Inclusion Criteria: * Provision of signed, written and dated informed consent * Healthy male Japanese volunteers aged 20-55 years * BMI between 18 and 27 kg/m2 * Have negative screens for HIV, hepatitis B and C viruses and syphilis Exclusion Criteria: * Use of prescribed medication within 2 weeks...