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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00520663 | Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug | PHASE1 | COMPLETED | 8 | — | — | Jun 8, 2007 | Aug 10, 2007 | Aug 2, 2017 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Healthy male subjects | EXPERIMENTAL | Each subject will receive a single oral dose of 14C-SB649868 (containing approximately 70 microcuries of radiocarbon and 30 milligrams of SB649868). |
| Name | Type | Description |
|---|---|---|
| 14C-SB649868 | DRUG | SB-649868 will be provided as powder in a bottle which will be reconstituted into a solution prior to dosing via a hard gelatin capsule. Each subject will receive one unit dose of SB-649868 30 milligram reconstituted powder presented in a size 00 capsule once. The capsule will be swallowed with 160 milliliters of water. |
Inclusion criteria: * Healthy males, aged 30-55 years inclusive. * Body weight more or equal to 50kg with a BMI (body mass index) between 18.5-29.9kg/m2 inclusive. * Healthy as based on a medical evaluation consisting of medical history, physical examination, lab tests on blood and urine and cardio...