Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ICA-105665 · 1 trial · 1 indication
| 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...
ICA-105665 is an investigational small molecule drug developed by Pfizer, Inc. (NYSE: PFE). It has been studied in a Phase 1 clinical trial in healthy male volunteers. Its therapeutic indication has not been disclosed.
ICA-105665 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 trial of the drug.
ICA-105665 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA.
ICA-105665 has been evaluated in one completed Phase 1 trial, NCT00962663, titled Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects. The trial enrolled 25 healthy male volunteers in the United Kingdom.
The Phase 1 trial NCT00962663 was a randomized, double-blind, placebo-controlled study. It enrolled 25 healthy male volunteers aged 18 years and older in the United Kingdom and has been completed.