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14C-SB649868 · 1 trial · 1 indication
| 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...
14C-SB649868 is an investigational small molecule being developed for sleep initiation and maintenance disorders, a type of insomnia. It is in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is intended to address difficulties falling asleep and staying asleep.
14C-SB649868 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research on this investigational drug for the treatment of sleep initiation and maintenance disorders.
14C-SB649868 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for sleep initiation and maintenance disorders.
14C-SB649868 has one completed Phase 1 clinical trial registered as NCT00520663, titled "Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug." The study enrolled 8 healthy male volunteers aged 30 years and older in the United Kingdom. The trial was uncontrolled and not blinded.
14C-SB649868 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for sleep initiation and maintenance disorders. The drug has not completed the clinical trials and regulatory review process required for marketing approval.