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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00426816 | To Evaluate The Effects Of SB-649868 (10, 30 Mg And 60 Mg) On Subjects With Primary Insomnia | PHASE2 | COMPLETED | 48 | — | — | Dec 1, 2006 | May 1, 2007 | Aug 13, 2012 | 10 | Germany |
| NCT00495729 | 15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects. | PHASE1 | COMPLETED | 36 | — | — | Apr 18, 2007 | Aug 4, 2007 | Aug 8, 2017 | 1 | Germany |
| NCT00440323 | Disturbed Sleep Model Study. | PHASE1 | COMPLETED | 52 | — | — | Jan 5, 2007 | Jul 3, 2007 | Aug 17, 2017 | 1 | United Kingdom |
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...