Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3031207 · 1 trial · 1 indication
AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module.
| Arm | Type | Description |
|---|---|---|
| LY3031207 | EXPERIMENTAL | Participants received escalating doses of 5 mg (milligrams), 25 mg, 75 mg, 225 mg, 450 mg and 900 mg of LY3031207 capsule orally. |
| Placebo | PLACEBO_COMPARATOR | Single dose of placebo administered orally in up to two occasions separated by at least a 3 week wash-out period between each dose. |
| Celecoxib | ACTIVE_COMPARATOR | Single 400mg dose of celecoxib administered orally on one occasion. |
| Name | Type | Description |
|---|---|---|
| LY3031207 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| Celecoxib | DRUG | Administered orally |
Inclusion Criteria: * Male subjects agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product * Women not of child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy w...
LY3031207 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and is in early clinical development. The only completed trial evaluated the drug in healthy subjects to assess its safety and tolerability.
LY3031207 is being developed by Eli Lilly and Company, traded on the New York Stock Exchange under the ticker LLY. The company sponsored the Phase 1 clinical trial of this investigational small molecule.
LY3031207 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The single Phase 1 trial has been completed, and the drug is not currently in any active clinical trials.
LY3031207 has one completed clinical trial, NCT01449630, titled "A Study of LY3031207 in Healthy Subjects." This Phase 1, randomized, double-blind, placebo-controlled study enrolled 29 participants in the United States and has been completed.
LY3031207 is not FDA approved. It is an investigational drug that has only been studied in a Phase 1 clinical trial in healthy volunteers. The trial has been completed, but the drug remains in clinical development and has not been approved for any use.