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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01968070 | A Study of LY3127760 in Healthy Participants | PHASE1 | COMPLETED | 80 | — | — | Oct 1, 2013 | Apr 1, 2014 | Jun 7, 2019 | 1 | United States |
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
| Arm | Type | Description |
|---|---|---|
| LY3127760 (Single) | EXPERIMENTAL | Single oral dose of up to 900 milligram (mg) LY3127760 administered in up to 3 of 3 study periods. |
| Placebo (Single) | PLACEBO_COMPARATOR | Single oral dose of placebo administered in up to 2 of 3 study periods. Placebo matches LY3127760 in appearance. |
| LY3127760 (Multiple) | EXPERIMENTAL | Multiple ascending oral doses of up to 900 mg LY3127760 administered once or twice daily (QD or BID) for 28 days. |
| Placebo (Multiple) | PLACEBO_COMPARATOR | Multiple oral doses of placebo administered QD or BID for 28 days. Placebo matches LY3127760 in appearance. |
| Celecoxib (Multiple) | ACTIVE_COMPARATOR | Multiple oral doses of 400 mg celecoxib administered QD for 28 days. |
| Name | Type | Description |
|---|---|---|
| LY3127760 | DRUG | Administered orally |
| Celecoxib | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
Inclusion Criteria: * Overtly healthy males or females as determined by medical history and physical examination * Male participants agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product * Female participants not of chil...