Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Digoxin Alone · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Session 1 digoxin alone, Session 2 retigabine plus digoxin | EXPERIMENTAL | Session 1: Single administration of digoxin (0.25mg) and PK assessments up to 144hrs post-dose. Session 2: Retigabine up-titration to 1200mg (TDD) with co-administration of digoxin (0.25mg) at 3 doses or retigabine during the up-titration (600mg, 900mg and 1200mg) and PK assessments up to 144hrs post-dose following wach co-administration. |
| Name | Type | Description |
|---|---|---|
| Digoxin Alone | DRUG | Single administration of digoxin 0.25mg |
| Digoxin + Retigabine | DRUG | Increasing doses of retigabine (300mg, 450mg, 600mg, 750mg, 900mg, 1050mg and 1200mg) administered as TID doses over 44 days. Co-administration with digoxin (0.25mg) on days 10, 24 and 38. |
Inclusion Criteria: * Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac...