Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SB649868 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Atorvastatin | EXPERIMENTAL | single dose session with Atorvastatin with PK samples collected up to 72h post dose, then 14 days repeat dose session with SB649868 with Atorvastatin single dose co-administered on day 8 (same time as SB649868) and on day 12 (2 hours before SB649868). |
| Cohort 2: Simvastatin | EXPERIMENTAL | single dose session with Simvastatin with PK samples collected up to 24h post dose, then 14 days repeat dose session with SB649868 with Simvastatin single dose co-administered on day 12 (same time as SB649868) and on day 14 (2 hours before SB649868). |
| Cohort 1: SB-649868 | EXPERIMENTAL | Healthy adult male subjects |
| Cohort 2 | EXPERIMENTAL | Healthy adult female subjects |
| Cohort 3 | EXPERIMENTAL | Healthy male elderly subjects |
| Cohort 4 | EXPERIMENTAL | Healthy female elderly subjects |
| Name | Type | Description |
|---|---|---|
| Atorvastatin | DRUG | 20mg single dose given alone and coadministered with SB649868 on day 8 and 12 of the 14-day repeat dose period. |
| Simvastatin | DRUG | 10mg single dose given alone and coadministered with SB649868 on day 12 and 14 of the 14-day repeat dose period. |
| SB649868 | DRUG | 20mg daily given for 14 days. |
| SB-649868 | DRUG | In each of all cohorts, 18 subjects will be randomised in a 2:1 ratio to receive either SB-649868 or placebo |
Inclusion Criteria: 1. Healthy male subject, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, neuropsychiatric status using the MINI International Neuropsychiatric Interview, laboratory tests and cardiac monitor...
SB-649868 is an investigational small molecule being developed for sleep disorders, specifically sleep initiation and maintenance disorders. It is in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied for its potential to treat conditions related to difficulty falling asleep or staying asleep.
SB-649868 is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for sleep disorders.
SB-649868 is in Phase 2 clinical development for sleep disorders. It is an investigational drug, meaning it has not yet received regulatory approval and is still undergoing clinical trials to assess its safety and effectiveness in treating sleep initiation and maintenance disorders.
SB-649868 has completed four Phase 1 clinical trials, including NCT00440323, NCT00495729, NCT01030939, and NCT01299597. These studies evaluated the drug's safety, tolerability, pharmacokinetics, and potential drug interactions in healthy volunteers. No active trials are currently listed for this drug.
SB-649868 is a distinct investigational compound developed by GSK plc. It is not known to be the same as any other marketed sleep medication. The drug is being studied specifically for sleep initiation and maintenance disorders, and its mechanism of action has not been publicly disclosed in available clinical trial information.