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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00903617 | Study to Test GSK256073 in Patients With Dyslipidemia | PHASE2 | COMPLETED | 80 | — | — | Jun 15, 2009 | Feb 16, 2010 | Dec 5, 2019 | 11 | United States |
| NCT00808093 | Repeat Dose Food Effect Study of GSK256073F in Healthy Adult Subjects | PHASE1 | COMPLETED | 30 | — | — | May 12, 2008 | Aug 27, 2008 | Jun 5, 2017 | 1 | United States |
The potential PK/PD relationship was to be assessed by plotting GSK256073 AUCs against HDLc. The PK/PD model that was to be used for the simulations in the study design was to be refined with the Part A observed AUC exposures and HDLc levels. However, the study was stopped for futility at the end of Part A due to lack of a compelling PK/PD relationship between GSK256073 and lipid effects that would predict success in achieving significant HDLc raising.
| Arm | Type | Description |
|---|---|---|
| Part A Treatment A | EXPERIMENTAL | 5 mg of GSK256073 |
| Part A Treatment B | EXPERIMENTAL | 50 mg of GSK256073 |
| Part A Treatment C | EXPERIMENTAL | 150 mg of GSK256073 |
| Part A Treatment D | PLACEBO_COMPARATOR | placebo |
| Part B Treatment A | PLACEBO_COMPARATOR | placebo |
| Part B Treatment B | ACTIVE_COMPARATOR | 1500 mg Niaspan |
| Part B Treatment C | EXPERIMENTAL | x mg dose of GSK256073 based on data from Part A |
| Part B Treatment D | EXPERIMENTAL | optional dose of GSK256073 based on data from Part A |
| fixed sequence | OTHER | fixed sequence (14 days fasted followed by 14 days either high fat or standard meal |
| Name | Type | Description |
|---|---|---|
| GSK256073 | DRUG | 5 mg for 8 weeks |
| Placebo | DRUG | placebo for 8 weeks |
| Niaspan | DRUG | 1500 mg for 8 weeks |
Inclusion Criteria: * Signed written informed consent prior to beginning study-related procedures. Subjects must understand the aims, investigational procedures and possible consequences of the study and must be able to understand and comply with protocol requirements, instructions and protocol-sta...