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Also known as Investigational Medicinal Product (MR1)
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 *...
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| Supernus Pharmaceuticals, Inc. | SUPN | 4 | PHASE2 | SPN-817, Treatment B, BIS-001ER |
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The Investigational Medicinal Product is being studied for epilepsy. It is an investigational small molecule developed by GSK plc. A Phase 1 trial evaluated modified release formulations of the drug in healthy adult volunteers with the goal of characterizing its pharmacokinetic performance at steady state.
GSK plc, which trades under the ticker GSK, is the developer of the Investigational Medicinal Product. The company sponsored the Phase 1 pharmacokinetic study of the drug in epilepsy. GSK plc is the sole company identified as developing this asset.
The Investigational Medicinal Product is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The completed study enrolled 36 participants and assessed repeat-dose pharmacokinetics of five modified release formulations compared with an immediate release formulation.
The Investigational Medicinal Product was studied in NCT01332513, a completed Phase 1 trial titled an open label, randomised, repeat dose study to assess the pharmacokinetic performance of five modified release formulations at steady state compared to the immediate release formulation. The trial enrolled 36 healthy adult volunteers in the United States.
Yes. The Investigational Medicinal Product is also known as Investigational Medicinal Product (MR1). The MR1 designation refers to the modified release formulations evaluated in the Phase 1 pharmacokinetic study. Both names refer to the same GSK plc epilepsy asset in Phase 1 development.
The Phase 1 trial NCT01332513 was an open label, randomized, controlled, repeat dose study. It compared five modified release formulations of the Investigational Medicinal Product against the immediate release formulation at steady state. The study enrolled 36 healthy volunteers aged 18 years and older in the United States and has been completed.