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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01362257 | A Study to Determine the Excretion Balance and Pharmacokinetics of 14C-GSK573719 | PHASE1 | COMPLETED | 6 | — | — | Apr 29, 2011 | Jun 22, 2011 | Jun 27, 2017 | 1 | Netherlands |
AUC(0-∞) = area under concentration time curve from time zero extrapolated to infinite time. AUC(0-t) = Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments. Cmax = Maximum observed concentration. tmax = Time of occurrence of Cmax. λz = Terminal phase rate constant. t1/2 = Terminal phase half life.
| Arm | Type | Description |
|---|---|---|
| 14C-GSK573719 Oral Solution | EXPERIMENTAL | single dose of 1000µg |
| 14C-GSK573719 IV Solution | EXPERIMENTAL | single dose of 65µg |
| Name | Type | Description |
|---|---|---|
| Treatment Period 1 - IV dose of GSK573719 | DRUG | single dose of 65µg |
| Treatment Period 2 - Oral dose of GSK573719 | DRUG | single dose of 1000µg |
Inclusion: AST (Aspartate aminotransferase), ALT (Alanine aminotransferase), alkaline phosphatase and bilirubin ≤ 1.5xULN (Upper limit of normal) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%) Healthy, non-smoking male subjects, 30-55 years old ...