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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00711386 | GSK706769 Repeat Dose Study | PHASE1 | COMPLETED | 40 | — | — | May 16, 2008 | Sep 12, 2008 | Aug 3, 2017 | 1 | United States |
Change from baseline values in clinical chemistry, hematology and urinalysis.
Change from baseline values
Change from baseline values
Area under the plasma concentration time curve (AUC(0-infinity), AUC(0-24)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), concentration at 24 hours post dose (C24), terminal half-life (t1/2), absorption lag time (tlag), apparent clearance (CL/F), metabolite-to-parent molar ratios for AUC(0-t) and Cmax; and following last repeat administration on Day 7 or 8: AUC(0-infinity), concentration at end of dosing interval (Ctau), Cmax, tlag, tmax, t1/2, and CL/F, metabolite-to-parent molar ratios for AUC(0-tau) and Cmax on Day 7 or 8.
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | 50mg dose once daily for 7 days. |
| Cohort B | EXPERIMENTAL | 100mg dose once daily for 8 days. |
| Cohort C | EXPERIMENTAL | 200mg dose once daily for 8 days. |
| Cohort D | EXPERIMENTAL | 400mg dose once daily for 7 days. |
| Name | Type | Description |
|---|---|---|
| GSK706769 | DRUG | 50mg, 100mg, 200mg, or 400mg |
| Placebo | OTHER | Placebo |
Inclusion Criteria: * Healthy as determined by a responsible 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 for the popula...