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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01154634 | Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects | PHASE2 | COMPLETED | 20 | — | — | May 1, 2010 | Sep 1, 2010 | Aug 30, 2012 | 2 | Belgium, Netherlands |
Total number of reflux episodes 0 to 3 hours post meal
| Arm | Type | Description |
|---|---|---|
| First 5 mg, then placebo, then 16 mg, then 40 mg | EXPERIMENTAL | period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg. |
| First 40 mg, then 16 mg, then placebo, then 5 mg | EXPERIMENTAL | period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg. |
| First 16 mg, then 5 mg, then 40 mg, then placebo | EXPERIMENTAL | period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo. |
| First placebo, then 40 mg, then 5 mg, then 16 mg | EXPERIMENTAL | period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg |
| Name | Type | Description |
|---|---|---|
| AZD2516, 5 mg | DRUG | Capsule, oral |
| AZD2516, 16 mg | DRUG | Capsule, oral |
| AZD2516, 40 mg | DRUG | Capsule, oral |
| Placebo | DRUG | Capsule, oral |
Inclusion Criteria: * Provision of signed informed consent * Healthy male subjects * Age 18-45 years, inclusive Exclusion Criteria: * Clinically significant illness within the 2 weeks prior to the first dose of study drug * History of clinically significant cardiovascular, respiratory, renal, hep...