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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01449630 | A Study of LY3031207 in Healthy Subjects | PHASE1 | COMPLETED | 29 | — | — | Oct 24, 2011 | Apr 2, 2012 | Jul 5, 2019 | 1 | United States |
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...