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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01480609 | Effect of Haemodialysis on the Pharmacokinetics of Ezogabine/Retigabine and Its N-acetyl Metabolite | PHASE1 | COMPLETED | 8 | — | — | Nov 30, 2011 | Apr 24, 2012 | Jun 19, 2018 | 1 | United States |
Pharmacokinetic parameters
Pharmacokinetic parameters
| Arm | Type | Description |
|---|---|---|
| Dose-Dialysis | ACTIVE_COMPARATOR | Subjects will be dosed with study drug followed by a scheduled dialysis session |
| Dialysis-Dose | ACTIVE_COMPARATOR | Subjects will be dosed following the completion of their scheduled dialysis session |
| Name | Type | Description |
|---|---|---|
| Retigabine / Ezogabine | DRUG | Retigabine / Ezogabine will be available as immediate release tablets of 50 milligrams strength. Subjects will be administered the tablet will 250 milliliters of water |
Inclusion Criteria: * Male or female 18 years or older, at the time of signing the informed consent. * ESRD patients with minimal or no residual renal function and receiving stabilised haemodialysis regimen. * Body mass index with the range of 18-42 kg/m2 at screening. * A female subject is eligibl...