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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00962663 | Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects | PHASE1 | COMPLETED | 25 | — | — | Aug 1, 2009 | Dec 1, 2009 | Sep 28, 2012 | 2 | United Kingdom, |
| Arm | Type | Description |
|---|---|---|
| ICA-105665 | EXPERIMENTAL | Three study drug treatments will be used: ICA-105665, ibuprofen, and placebo (for both ICA-105665 and Ibuprofen). The order of study drug treatment given to each subject during each specified treatment period is determined at randomization. |
| Ibuprofen | ACTIVE_COMPARATOR | Three study drug treatments will be used: ICA-105665, ibuprofen, and placebo (for both ICA-105665 and Ibuprofen). The order of study drug treatment given to each subject during each specified treatment period is determined at randomization. |
| Placebo | PLACEBO_COMPARATOR | Three study drug treatments will be used: ICA-105665, ibuprofen, and placebo (for both ICA-105665 and Ibuprofen). The order of study drug treatment given to each subject during each specified treatment period is determined at randomization. |
| Name | Type | Description |
|---|---|---|
| ICA-105665 | DRUG | Subjects randomized to receive ICA -105665 will receive 200 mg BID |
| Ibuprofen | DRUG | Subjects randomized to receive Ibuprofen will receive placebo to ICA-105665 at all scheduled dosing times on Days 1 to 4 and a single dose of 800 mg Ibuprofen on the morning of Day 4. |
| Placebo | DRUG | Subjects randomized to receive placebo will receive placebo to ICA -105665 at all scheduled dosing times on Days 1 to 4 and placebo to Ibuprofen on the morning of Day 4. |
Inclusion Criteria: * Healthy males aged 18 to 55 years (inclusive). * Body mass index (BMI) of 18 to 30 kg/m2. * Non-smokers and smokers of up to 5 cigarettes or equivalent per day. * Must be able to abstain from smoking during residential periods. * Demonstration of positive hyperalgesia as defin...