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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01681186 | A Study of LY2940680 in Healthy Participants | PHASE1 | COMPLETED | 30 | — | — | Sep 1, 2012 | Dec 1, 2012 | Oct 21, 2019 | 1 | United States |
Data presented are the number of participants with AEs or any serious AEs (SAEs) regardless of causality. A summary of non-serious AEs is located in the Reported Adverse Events section.
The Cmax of 100-milligram (mg) LY2940680 capsule (reference formulation) and 100-mg LY2940680 tablet (test formulation) in fasted and fed state, and with lansoprazole during Part B of the study.
| Arm | Type | Description |
|---|---|---|
| LY2940680 (Part A) | EXPERIMENTAL | Single escalating dose (50 mg up to 400 mg) of LY2940680 given once orally in up to 2 of 2 study periods |
| Placebo (Part A) | PLACEBO_COMPARATOR | Placebo given once orally in up to 1 of 2 study periods |
| LY2940680 Capsule Fasted (Part B) | EXPERIMENTAL | 100 mg LY2940680 given once orally as a capsule (reference formulation) in fasted state in 1 of 4 study periods |
| LY2940680 Tablet Fasted (Part B) | EXPERIMENTAL | 100 mg LY2940680 given once orally as a tablet (test formulation) in fasted state in 1 of 4 study periods |
| LY2940680 Tablet Fed (Part B) | EXPERIMENTAL | 100 mg LY2940680 given once orally as a tablet (test formulation) in fed state following a standardized, high-fat breakfast in 1 of 4 study periods |
| LY2940680 Tablet Fasted + PPI (Part B) | EXPERIMENTAL | 30 mg lansoprazole (PPI) given orally once daily for 7 days. One hour after last dose, 100 mg LY2940680 given orally once as a tablet (test formulation) in fasted state in 1 of 4 study periods |
| Name | Type | Description |
|---|---|---|
| LY2940680 Capsule(s) (Reference) | DRUG | Administered orally as a capsule(s) |
| LY2940680 Tablet (Test) | DRUG | Administered orally as a tablet |
| Lansoprazole | DRUG | Administered orally as a capsule |
| Placebo Capsule(s) | DRUG | Administered orally as a capsule(s) |
Inclusion Criteria: * Healthy sterile males or surgically sterile females or postmenopausal females, as determined by medical history and physical examination * Body mass index of 18.5 to 32.0 kilograms per meter square (kg/m\^2) * Have clinical laboratory test results within normal reference range...