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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01640990 | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intravenous Infusion of GW328267X in Healthy Volunteers | PHASE1 | COMPLETED | 3 | — | — | Nov 22, 2011 | Dec 9, 2011 | Jun 12, 2017 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | slow IV infusion over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5 hours (total dose of 12mcg), and 10 mcg/h GW328267X for 4 hours (total dose of 40 mcg) |
| Cohort 2 | EXPERIMENTAL | Dose to be determined after analysis of Cohort 1 |
| Name | Type | Description |
|---|---|---|
| Saline | DRUG | 30mins run-in period |
| GW328267X (total dose of 12mcg) | DRUG | 8 mcg/h for 1.5 hours (total dose of 12mcg) |
| GW328267X (total dose of 40mcg) | DRUG | 10 mcg/h for 4 hours (total dose of 40 mcg) |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range ...