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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01299597 | A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. | PHASE1 | COMPLETED | 30 | — | — | Jan 18, 2010 | Feb 26, 2010 | Jul 21, 2017 | 1 | Germany |
| NCT01030939 | Study to Investigate Safety, Tolerability, Pharmacokinetics and Cardiac Function After Repeat Doses of SB-649868 in Healthy-volunteers | PHASE1 | COMPLETED | 72 | — | — | Aug 27, 2009 | Jan 6, 2010 | Jun 20, 2017 | 1 | Germany |
| 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...