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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00909636 | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of the ABT-333 Tablet | PHASE1 | COMPLETED | 24 | — | — | May 1, 2009 | - | Oct 13, 2010 | 1 | United States |
| NCT00895102 | Bioavailability of ABT-333 Tablet Versus First in Human (FIH) Capsule Formulation and Safety, Tolerability and PK Study of Single Doses of ABT-333 in Healthy Volunteers | PHASE1 | COMPLETED | 34 | — | — | Apr 1, 2009 | - | Oct 13, 2010 | 1 | United States |
| NCT00768690 | A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333 | PHASE1 | COMPLETED | 45 | — | — | Oct 1, 2008 | - | Oct 13, 2010 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1. ABT-333 Tablet | ACTIVE_COMPARATOR | Three 400mg ABT-333 Tablets, BID |
| 2. ABT-333 Tablet | ACTIVE_COMPARATOR | Four 400mg ABT-333 Tablets, BID |
| 3. Placebo | PLACEBO_COMPARATOR | Three or four placebo tablets, BID |
| 1. ABT-333 Capsule vs ABT-333 Tablet | ACTIVE_COMPARATOR | 400mg ABT-333 Tablet, QD, single dose vs eight 50mg ABT-333 Capsules, QD, single dose |
| 1 | OTHER | Healthy volunteers, receiving daily doses of 200 mg ABT-333 or placebo, BID for 10 days; and on Study Day 11 receiving a single dose of 200 mg ABT-333 or placebo + 400 mg ketoconazole |
| 2 | OTHER | Healthy volunteers, receiving 400 mg ABT-333 or placebo, BID |
| 3 | OTHER | Healthy volunteers, receiving 600mg ABT-333 or placebo, BID |
| 4 | OTHER | Healthy volunteers, receiving 1000mg ABT-333 or placebo, BID |
| 5 | OTHER | Healthy volunteers, receiving 1600mg ABT-333 or placebo, BID\* \*After review of the data from previous groups, and in accordance with the protocol, this arm was not dosed. |
| Name | Type | Description |
|---|---|---|
| ABT-333 | DRUG | See arm description for more information |
| Placebo | DRUG | See arm description for more information |
| ABT-333 Tablet | DRUG | See Arm Description for more information. |
| ABT-333 Capsule | DRUG | See arm description for more information |
| ketoconazole | DRUG | Tablet, see arms for intervention description |
Inclusion Criteria: * overall healthy subjects between the ages of 18 to 55 years old; * if female, subject must be either postmenopausal for at least 2 years or surgically sterile; * females must have negative results for pregnancy tests performed; * if male, subject must be surgically sterile or ...