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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01539473 | A Phase 1 TR-701 FA Study of Blood Pressure Response Post Tyramine Challenge | PHASE1 | COMPLETED | 30 | — | — | Feb 1, 2012 | May 1, 2012 | May 3, 2016 | 1 | United States |
To assess tyramine dose required to cause increase of 30 mmHg in systolic blood pressure
| Arm | Type | Description |
|---|---|---|
| TR-701 FA with Tyramine | EXPERIMENTAL | TR-701 FA 200 oral with Tyramine |
| Placebo-controlled with Tyramine | PLACEBO_COMPARATOR | Placebo-controlled with Tyramine |
| Name | Type | Description |
|---|---|---|
| TR-701 FA with Tyramine | DRUG | TR-701 FA 200 mg oral and Tyramine |
| Placebo-controlled withTyramine | DRUG | Placebo-controlled and Tyramine |
Inclusion Criteria: * Male or female subjects between 18 to 45 years of age, inclusive * Body mass index between 19 kg/m2 and 31 kg/m2, inclusive * Healthy subjects with no clinically significant abnormalities identified by a detailed medical history, Exclusion Criteria: * Systolic blood pressure...