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...
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Digoxin Alone refers to the use of digoxin as a standalone treatment in a Phase 1 drug interaction study. The trial evaluated the pharmacokinetics of digoxin when given alone and when co-administered with ezogabine/retigabine in healthy adult volunteers. Digoxin is a small molecule being studied in epilepsy.
Digoxin Alone targets the ATP1A1, ATP1B2, ATP1B1, ATP1A2, ATP1B3, and ATP1A3 subunits of the sodium-potassium ATPase. It acts as an inhibitor of these targets. This mechanism is being explored in the context of epilepsy.
Digoxin Alone is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical trial evaluating this treatment.
Digoxin Alone is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 1 trial has been completed.
Digoxin Alone has been evaluated in one completed Phase 1 trial, NCT01583036. This open-label, single-center study enrolled 30 healthy adult volunteers and assessed the pharmacokinetics of digoxin alone and with ezogabine/retigabine in epilepsy.