Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Zolpidem
SB649868 · 4 trials · 2 indications
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: 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 |
| 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. |
| 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...
SB649868 is an investigational small molecule developed by GSK plc for sleep disorders, including sleep initiation and maintenance disorders. It has been studied in Phase 1 and Phase 2 clinical trials, primarily in healthy volunteers and in subjects with primary insomnia. It is not described as an approved medicine.
SB649868 was studied for sleep disorders, specifically sleep initiation and maintenance disorders. Trials enrolled healthy volunteers and subjects with primary insomnia to evaluate its effects on disturbed sleep. The completed studies examined dosing, safety, tolerability, pharmacokinetics, and cardiac function rather than establishing an approved use.
SB649868 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical program, including Phase 1 studies in Germany and the United Kingdom and a Phase 2 study in subjects with primary insomnia. No partner or licensing arrangement is described for this asset.
SB649868 is in Phase 1 development, with a Phase 2 study also completed. It is an investigational drug and is not described as FDA approved. All four listed trials are completed, and none are currently active, so the program is not enrolling new participants at this time.
SB649868 has been studied in completed trials including NCT01030939, a Phase 1 repeat-dose safety, tolerability, pharmacokinetics and cardiac function study in 72 healthy volunteers; NCT00495729, a 15-day repeat-dose and CYP3A4 interaction study in 36 healthy men; NCT00440323, a disturbed sleep model study in 52 men; and NCT00426816, a Phase 2 study of 10, 30 and 60 mg in 48 subjects with primary insomnia.
Yes, SB649868 and SB-649868 refer to the same investigational compound from GSK plc. The hyphenated form SB-649868 appears in the registered clinical trial titles, while SB649868 is the unhyphenated spelling. Both names describe the same small molecule studied for sleep initiation and maintenance disorders.