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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01534273 | A Study of LY2886721 in Healthy Participants | PHASE1 | COMPLETED | 30 | — | — | Feb 1, 2012 | Jul 1, 2012 | Aug 28, 2019 | 1 | United States |
| NCT01367262 | Disposition of Carbon-14-Labeled LY2886721 ([^14C]-LY2886721) Following Oral Administration in Healthy Human Participants | PHASE1 | COMPLETED | 6 | — | — | Jun 1, 2011 | Jul 1, 2011 | Sep 13, 2019 | 1 | United States |
Data presented are the number of participants who experienced treatment-emergent adverse events. A summary of serious adverse events and other non-serious adverse events, regardless of causality is reported in the Adverse Events module.
Urinary and fecal excretion of LY2886721 radioactivity over time was expressed as a percentage of the total radioactive dose administered. The amount of drug-related material excreted in urine and feces (Ae) at a specific collection interval (i) was calculated as the product of radioactivity concentration and volume or weight. The Ae values for each collection interval were then summed and calculated as Total Ae=Ae(i1)+Ae(i2)+Ae(in). The percentage of the total radiolabeled dose administered that was excreted in feces or urine=\[(Total Ae)/(Total radioactive dose administered)\]\*100.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Single oral dose and/or once daily (QD) oral dosing for 14 consecutive days |
| 35 mg LY2886721 | EXPERIMENTAL | QD oral dosing for 14 consecutive days |
| 70 mg LY2886721 | EXPERIMENTAL | Single oral dose or single oral dose followed by QD oral dosing for 14 consecutive days |
| 140 mg LY2886721 | EXPERIMENTAL | Single oral dose |
| Radiolabeled LY2886721 | EXPERIMENTAL | Single 25 milligram (mg) oral dose containing 80 microCuries of radiolabeled LY2886721 |
| Name | Type | Description |
|---|---|---|
| LY2886721 | DRUG | Administered orally. |
| Placebo | DRUG | Administered orally. |
Inclusion Criteria: * Healthy men and non-childbearing potential women * Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m\^2) * Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit ...