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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02184429 | A Study To Understand Safety And Plasma Concentrations Of PF-06669571 During And Following The Oral Administration Of Single And Multiple Doses Of PF-06669571 In Healthy Volunteers Under Fasted And Fed Conditions | PHASE1 | COMPLETED | 56 | — | — | Jul 1, 2014 | Mar 1, 2015 | Sep 6, 2018 | 1 | United States |
C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").
| Arm | Type | Description |
|---|---|---|
| Single Ascending Dose-1 | EXPERIMENTAL | Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design |
| Single Ascending Dose-2 | EXPERIMENTAL | Single ascending doses of PF-06669571 administered to healthy volunteers in a cross over study design |
| Multiple Ascending Dose-1 | EXPERIMENTAL | Daily dose of PF-06669571 in healthy volunteers |
| Multiple Ascending Dose-2 | EXPERIMENTAL | Daily dose of PF-06669571 in healthy volunteers |
| Multiple Ascending Dose-3 | EXPERIMENTAL | Daily dose of PF-06669571 in healthy volunteers |
| Multiple Ascending Dose-4 | EXPERIMENTAL | Daily dose of PF-06669571 in healthy volunteers |
| Multiple Ascending Dose-5 | EXPERIMENTAL | Daily dose of PF-06669571 in healthy volunteers |
| Name | Type | Description |
|---|---|---|
| PF-06669571 | DRUG | Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo |
Inclusion Criteria: * Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse ...