Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Investigational Medicinal Product · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| ABFCED sequence | EXPERIMENTAL | Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 milligram (mg) twice daily (BID) dosing of ezogabine modified release (MR) tablet in periods A, B, C, D and E and will receive 200 mg three times daily (TID) dosing of ezogabine immediate release (IR) tablet in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase. |
| BCADFE sequence | EXPERIMENTAL | Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 mg BID dosing of ezogabine MR in periods A, B, C, D and E and will receive 200 mg TID dosing of ezogabine IR in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase. |
| CDBEAF sequence | EXPERIMENTAL | Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 mg BID dosing of ezogabine MR in periods A, B, C, D and E and will receive 200 mg TID dosing of ezogabine IR in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase. |
| DECFBA sequence | EXPERIMENTAL | Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 mg BID dosing of ezogabine MR in periods A, B, C, D and E and will receive 200 mg TID dosing of ezogabine IR in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase. |
| EFDACB sequence | EXPERIMENTAL | Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 mg BID dosing of ezogabine MR in periods A, B, C, D and E and will receive 200 mg TID dosing of ezogabine IR in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase. |
| FAEBDC sequence | EXPERIMENTAL | Each subject will participate in six study periods in the bioavailability phase, wherein the subjects will receive a 300 mg BID dosing of ezogabine MR in periods A, B, C, D and E and will receive 200 mg TID dosing of ezogabine IR in period F. Following the completion of the crossover phase, subjects will be re-randomized to one of five cohorts receiving 600 mg doses of either G, H, I, J or K for the food effect phase. |
| Name | Type | Description |
|---|---|---|
| Investigational Medicinal Product (MR1) | DRUG | Ezogabine MR1 at a dose strength of 300 mg will be orally administered with approximately 250 milliliter (mL) of water to group A subjects during the bioavailability phase. For the food effect phase subjects in group G will be orally administered MR1 tablets at a dose strength of 600 mg. |
| Investigational Medicinal Product (MR2) | DRUG | Ezogabine MR2 at a dose strength of 300 mg will be orally administered to group B subjects with approximately 250 mL of water during the bioavailability phase. For the food effect phase subjects in group H will be orally administered MR2 tablets at a dose strength of 600 mg. |
| Investigational Medicinal Product (MR3) | DRUG | Ezogabine MR3 will be orally administered with approximately 250 mL of water to group C subjects during the bioavailability phase. For the food effect phase subjects in group I will be orally administered MR3 tablets at a dose strength of 600 mg. |
| Investigational Medicinal Product (MR4) | DRUG | Ezogabine MR4 will be orally administered with approximately 250 mL of water to group D subjects during the bioavailability phase. For the food effect phase subjects in group J will be orally administered MR4 tablets at a dose strength of 600 mg. |
| Investigational Medicinal Product (MR5) | DRUG | Ezogabine MR5 will be orally administered with approximately 250 mL of water to group E subjects during the bioavailability phase. For the food effect phase subjects in group K will be orally administered MR5 tablets at a dose strength of 600 mg. |
| Investigational Medicinal Product (IR) | DRUG | Ezogabine IR at dose strengths of 50 mg and 200 mg will be orally administered with approximately 250 mL of water. |
Inclusion Criteria: 1. Healthy as determined by a responsible and experienced physician 2. Male or female between 18 and 60 years of age inclusive, at the time of signing the informed consent. 3. A female subject is eligible to participate if she is of: * Non-childbearing potential defined *...
Investigational Medicinal Product is a small molecule being developed by GSK plc for the treatment of epilepsy. It is currently in Phase 1 clinical development, meaning it is still investigational and has not been approved for use. The drug is being studied in patients with epilepsy to evaluate its pharmacokinetic properties.
The molecular target of Investigational Medicinal Product has not been disclosed. The drug is a small molecule being developed for epilepsy, but its specific mechanism of action is not publicly available. GSK plc is conducting clinical trials to evaluate its pharmacokinetic performance, but the target has not been specified.
Investigational Medicinal Product is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in patients with epilepsy.
Investigational Medicinal Product is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a Phase 1 trial to assess its pharmacokinetic performance in patients with epilepsy.
Investigational Medicinal Product has one completed Phase 1 clinical trial, identified as NCT01332513. This was an open-label, randomized, repeat-dose study that assessed the pharmacokinetic performance of five modified release formulations compared to an immediate release formulation. The trial enrolled 36 participants with epilepsy in the United States.
Investigational Medicinal Product is not a name for ezogabine or retigabine. The Phase 1 trial NCT01332513 studied ezogabine/retigabine modified release formulations, but the investigational medicinal product itself is a separate drug being developed by GSK plc for epilepsy. The drug's alternative names have not been disclosed.