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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01262885 | A Randomized, Single Blind, Placebo Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses and Repeat Escalating Oral Doses of GSK2251052 in Healthy Adult Subjects | PHASE1 | COMPLETED | 84 | — | — | Oct 7, 2010 | Aug 25, 2011 | Jun 28, 2017 | 1 | Australia |
| Arm | Type | Description |
|---|---|---|
| Part A Cohort 1 | EXPERIMENTAL | GSK2251052 500 mg (6 subjects), Placebo (1 subject) |
| Part A Cohort 2 | EXPERIMENTAL | GSK2251052 1000 mg (6 subjects), Placebo (1 subject) |
| Part A Cohort 3 | EXPERIMENTAL | GSK2251052 2000 mg (6 subjects), Placebo (1 subject) |
| Part A Cohort 2 - fed | EXPERIMENTAL | GSK2251052 1000 mg (6 subjects), Placebo (1 subject) |
| Part B Cohort 1 | EXPERIMENTAL | Placebo (3 subjects), GSK2251052 (9 subjects) dose to be determined |
| Part B Cohort 2 | EXPERIMENTAL | Placebo (3 subjects), GSK2251052 (9 subjects) dose to be determined |
| Part B Cohort 3 | EXPERIMENTAL | Placebo (3 subjects), GSK2251052 (9 subjects) dose to be determined |
| Part A Cohort 4 | EXPERIMENTAL | Placebo (1 subject), GSK2251052 (6 subjects) dose to be determined |
| Name | Type | Description |
|---|---|---|
| GSK2251052 | DRUG | 500 mg tablet, dose levels detailed in Arm description |
| Placebo | DRUG | matching placebo tablet |
Inclusion Criteria: * AST, ALT, alkaline phosphatase and bilirubin \< or = 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Abnormal LFT tests may be repeated once at the discretion of the Investigator. If an abnormality is repeated, th...