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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01545570 | A Study to Determine the Safety, Tolerability, and Effects of GSK2374697 in Healthy Volunteers | PHASE1 | COMPLETED | 82 | — | — | Nov 7, 2011 | Dec 23, 2012 | Jul 25, 2017 | 1 | United States |
Adverse events, laboratory parameters, ECGs, and vital signs
Pharmacokinetics parameters: AUCs, Cmax, tmax, elimination half-life (t½), lag time (tlag), apparent clearance (CL/F) and apparent volume of distribution (V/F), area under the plasma drug concentration versus time curve on Days 1 through end of study (up to 70 Days)
| Arm | Type | Description |
|---|---|---|
| GSK2376497 | ACTIVE_COMPARATOR | single dose escalation or multiple-dose titration |
| 0.9% sodium chloride | PLACEBO_COMPARATOR | placebo injection |
| Name | Type | Description |
|---|---|---|
| GSK2376497 | DRUG | GSK2376497 Active Comparator |
| 0.9% sodium chloride | DRUG | 0.9% sodium chloride Placebo Comparator |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and Holter monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range f...