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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00996268 | An Open-label Single Dose Randomized, Parallel Group Study Followed by Single-blind Repeat Dosing, to Compare the Relative Bioavailability of GSK2212836. | PHASE1 | COMPLETED | 46 | — | — | Oct 15, 2009 | Jan 4, 2010 | Jun 22, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | Three groups of sixteen healthy subjects will be randomized to single doses of 3 different formulations of GSK2212836. |
| Part B | EXPERIMENTAL | Four cohorts of at least 10 subjects will participate in a 2-week repeat dose period with 4 dose levels (based on data obtained in Part A) of the GSK2212836 test formulations or placebo. |
| Name | Type | Description |
|---|---|---|
| GSK2212836 | DRUG | Treatment A - GSK2212836 test formulation 1, Treatment B - GSK2212836 test formulation 2, or Treatment C -GSK2212836 marketed formulation. |
Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin less than 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including \[me...