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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00931281 | Study in Healthy Adults to Evaluate Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir | PHASE1 | COMPLETED | 38 | — | — | Jun 1, 2009 | - | Oct 13, 2010 | 1 | United States |
| NCT00909311 | Study in Healthy Adults to Evaluate Effect of Food on Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir | PHASE1 | COMPLETED | 8 | — | — | May 1, 2009 | - | Oct 13, 2010 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | ABT-450/ritonavir |
| 2 | PLACEBO_COMPARATOR | Placebo for ABT-450/placebo for ritonavir |
| Name | Type | Description |
|---|---|---|
| ABT-450 | DRUG | capsules, QD or BID, 14 days, ascending doses |
| ritonavir | DRUG | capsules, QD or BID, 14 days, ascending doses |
| Placebo for ABT-450 | DRUG | capsule, QD or BID, 14 days |
| Placebo for ritonavir | DRUG | capsule, QD or BID, 14 days |
Inclusion Criteria: * overall healthy subjects * non-childbearing potential females included Exclusion Criteria: * history of significant sensitivity to any drug * positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab * history of gastrointestinal issues or procedures * history of seizures...