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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02504476 | Multiple Ascending Dose Study on Safety, Tolerability, and Pharmacokinetics of AMG 581 in Healthy Subjects or Subjects With Schizophrenia or Schizoaffective | PHASE1 | COMPLETED | 52 | — | — | Aug 1, 2015 | Feb 1, 2016 | Mar 7, 2016 | 2 | United States |
| NCT02567370 | Single-ascending Dose Study With a Food-Effect Cohort to Evaluate AMG 581 | PHASE1 | COMPLETED | 70 | — | — | Aug 1, 2015 | Oct 1, 2015 | Oct 23, 2015 | 1 | United States |
Number and percent of subjects experiencing adverse events
Summaries over time and/or changes from baseline over time in systolic and/or diastolic blood pressure
Summaries over time and/or changes from baseline over time in heart rate
Summaries over time and/or changes from baseline over time in respiratory rate
Summaries over time and/or changes from baseline over time in temperature
Summaries over time and/or changes from baseline over time in ECGs
Subjects' maximum change from baseline in QTc and the number and percentage of subjects in each group
Subjects' maximum post-baseline values and the number and percentage of subjects in each group
Summaries over time and/or changes from baseline over time in changes in Simpson Angus Scale (SAS) score
Summaries over time and/or changes from baseline over time in in Barnes Akathisia Rating Scale (BARS) score
Subject incidence of treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) summarized by cohort
Summaries over time and/or changes from baseline over time in Barnes Akathisia Rating Scale (BARS) score
Subject incidence of treatment-emergent suicidal ideation and behavior as measured by Columbia-Suicide Severity Rating Scale (C-SSRS) summarized by cohort
| Arm | Type | Description |
|---|---|---|
| AMG 581 - Dose 1 | ACTIVE_COMPARATOR | - |
| AMG 581 - Dose 2 | ACTIVE_COMPARATOR | - |
| AMG 581 - Dose 3 | ACTIVE_COMPARATOR | - |
| AMG 581 - Dose 4 | ACTIVE_COMPARATOR | - |
| Placebo - Dose 1 | PLACEBO_COMPARATOR | - |
| Placebo - Dose 2 | PLACEBO_COMPARATOR | - |
| Placebo - Dose 3 | PLACEBO_COMPARATOR | - |
| Placebo - Dose 4 | PLACEBO_COMPARATOR | - |
| AMG 581/Midazolam - Drug Interaction | OTHER | - |
| Placebo | PLACEBO_COMPARATOR | - |
| AMG 581 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AMG 581 | DRUG | Active drug |
| Placebo | DRUG | Placebo |
| Midazolam | DRUG | Interaction |
Inclusion Criteria: \- Provided informed consent prior to initiation of any study-specific activities/procedures; -male or female subjects should be between the ages of 18 and 45 years (18-55 years for subjects with schizophrenia);-non-nicotine or non-tobacco (healthy subjects only); - no history o...