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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00550381 | Study Evaluating the Safety, Tolerability, and Pharmacokinetics (PK) of HKI-357 Administered Orally to Healthy Subjects | PHASE1 | COMPLETED | 72 | — | — | Jan 1, 2008 | Mar 1, 2008 | Jul 10, 2009 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | 10mg |
| 2 | PLACEBO_COMPARATOR | 20mg |
| 3 | PLACEBO_COMPARATOR | 40mg |
| 4 | PLACEBO_COMPARATOR | 80mg |
| 5 | PLACEBO_COMPARATOR | 160mg |
| 6 | PLACEBO_COMPARATOR | 240mg |
| 7 | PLACEBO_COMPARATOR | 400mg |
| 8 | PLACEBO_COMPARATOR | 640mg |
| 9 | PLACEBO_COMPARATOR | 960mg |
| 10 | PLACEBO_COMPARATOR | placebo |
| Name | Type | Description |
|---|---|---|
| HKI-357 | DRUG | Single-dose capsule |
Eligibility Criteria: * Healthy adult men or women of nonchildbearing potential, aged 18-50.