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SB-649868 · 3 trials · 1 indication
Statistical paramaters of sleep measured by analysis of Polysomnography during night section of subject visit. Measured for one night during each 4 study visits and twice at screening. All visits will take in total approximately 9 weeks from screening to follow-up.
| Arm | Type | Description |
|---|---|---|
| Crossover population | EXPERIMENTAL | All study population receive placebo and doses of SB-649868 at 10mg, 30mg and 60mg in a crossover desing |
| Cohort 1 | EXPERIMENTAL | Subjects in Cohort 1 will be randomized to receive 5 milligram (mg) of SB-649868 or Placebo along with 10 mg of simvastatin. |
| Cohort 2 | EXPERIMENTAL | Subjects in Cohort 2 will be randomized to receive two or three times higher than the starting dose of SB-649868 or Placebo along with 10 mg of simvastatin. |
| Cohort 3 | EXPERIMENTAL | Subjects in Cohort 3 will be randomized to dose higher than that administered in Cohort 2 of SB-649868 or Placebo along with 10 mg of simvastatin. |
| ADBC sequence | EXPERIMENTAL | In ADBC sequence A is Placebo, B is SB-649868 10 milligram (mg), C is SB-649868 30 mg, and D is Zolpidem 10 mg. Subject will receive placebo tablets, then two 5 mg tablets of SB-649868, then 25 mg and 5 mg tablet of SB-649868. There will be wash-out period of 7 days. |
| BACD sequence | EXPERIMENTAL | In BACD sequence subject will receive SB-649868 two tablets of 5 mg each (10 mg, B), Placebo tablets (A), SB-649868 two tablets of 25 mg and 5 mg (30 mg, C), and Zolpidem 10 mg (D). There will be wash-out period of 7 days. |
| CBDA sequence | EXPERIMENTAL | In CBDA sequence subject will receive SB-649868 two tablets of 25 mg and 5 mg (30 mg, C), SB-649868 two tablets of 5 mg each (10 mg, B), Zolpidem 10 mg (D) and Placebo tablet (A). There will be wash-out period of 7 days. |
| DCAB sequence | EXPERIMENTAL | In DCAB sequence subject will receive Zolpidem 10 mg (D), SB-649868 two tablets of 25 mg and 5 mg (30 mg, C), Placebo tablet (A), and SB-649868 two tablets of 5 mg each (10 mg, B). There will be wash-out period of 7 days. |
| Name | Type | Description |
|---|---|---|
| SB-649868 | DRUG | Active compound at doses of 10mg, 30mg and 60mg |
| Placebo | DRUG | Placebo to match SB-649868 |
| Simvastatin | DRUG | Subjects will receive Simvastatin 10 mg tablets orally. |
| Zolpidem | DRUG | Zolpidem capsules will be available with dose strength of 10 mg. |
Inclusion Criteria: * Male * 18-64 years of age (inclusive), * Diagnosis of primary insomnia who have had symptoms for at least three months. Exclusion Criteria: * Any clinically significant unstable medical or surgical condition (treated or untreated). * Any history of a clinically significant a...
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.