A Phase 1 interventional study of Investigational Medicinal Product (MR1) and Investigational Medicinal Product (MR2) in Epilepsy, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-19.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
This is an open-label, single centre, repeat dose, up- titration study in healthy male and female subjects to assess the pharmacokinetic (PK) performance of five prototypes of ezogabine modified release tablet formulations.
The study will consist of a screening period, a treatment phase (consisting of a titration phase, bioavailability phase and food effect phase) and a post-treatment follow-up visit. The study duration from screening to follow up will be approximately 7 weeks. No study procedures will start before informed consent is obtained. Subjects will remain in the clinical unit for the duration of the treatment period (35 days).
Subjects will receive repeat doses of ezogabine for up to 34 days starting at a dose of 100 mg IR TID (300mg TDD) with a standard meal (to be consumed 30 min prior to dosing) for Days 1-3, on days 4-6 subjects will receive 150mg IR TID (450mg TDD). On Day 7 through to the end of the study subjects will receive ezogabine (Mr or IR) at a dose of 600mgTDD.
On Day 7 subjects will enter into a 6-way cross over period to investigate the 5 MR formulations being tested (each at 300mg BID) and the single IR formulation (at 200mg TID). Subjects will receive each formulaition for 4 days and blood samples for pharmacokinetic analysis will be collected up to 24 hours post dose on each 4th day (PK days).
On Day 31 subjects will enter into a food effect phase to investigate the 5 MR formulations being tested (each at 600mg QD). Subjects in this period will have a PK day on Day 33 (following a standard breakfast), and on Day 34 (following a high fat breakfast) to investigate a food effect on the PK profile of ezogabine.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 36 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
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A female subject is eligible to participate if she is of:
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
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.
Drug: Investigational Medicinal Product (MR1) · Drug: Investigational Medicinal Product (MR2) · Drug: Investigational Medicinal Product (MR3) · Drug: Investigational Medicinal Product (MR4) · Drug: Investigational Medicinal Product (MR5) · Drug: Investigational Medicinal Product (IR)
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.
Drug: Investigational Medicinal Product (MR1) · Drug: Investigational Medicinal Product (MR2) · Drug: Investigational Medicinal Product (MR3) · Drug: Investigational Medicinal Product (MR4) · Drug: Investigational Medicinal Product (MR5) · Drug: Investigational Medicinal Product (IR)
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.
Drug: Investigational Medicinal Product (MR1) · Drug: Investigational Medicinal Product (MR2) · Drug: Investigational Medicinal Product (MR3) · Drug: Investigational Medicinal Product (MR4) · Drug: Investigational Medicinal Product (MR5) · Drug: Investigational Medicinal Product (IR)
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.
Drug: Investigational Medicinal Product (MR1) · Drug: Investigational Medicinal Product (MR2) · Drug: Investigational Medicinal Product (MR3) · Drug: Investigational Medicinal Product (MR4) · Drug: Investigational Medicinal Product (MR5) · Drug: Investigational Medicinal Product (IR)
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.
Drug: Investigational Medicinal Product (MR1) · Drug: Investigational Medicinal Product (MR2) · Drug: Investigational Medicinal Product (MR3) · Drug: Investigational Medicinal Product (MR4) · Drug: Investigational Medicinal Product (MR5) · Drug: Investigational Medicinal Product (IR)
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.
Drug: Investigational Medicinal Product (MR1) · Drug: Investigational Medicinal Product (MR2) · Drug: Investigational Medicinal Product (MR3) · Drug: Investigational Medicinal Product (MR4) · Drug: Investigational Medicinal Product (MR5) · Drug: Investigational Medicinal Product (IR)
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.
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.
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.
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.
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.
Ezogabine IR at dose strengths of 50 mg and 200 mg will be orally administered with approximately 250 mL of water.
Area under the curve from zero to 24 hours at steady-state of ezogabine
Time frame: Days 10, 14, 18, 22, 26 and 30
Area under the curve of ezogabine from zero to 24 hours at steady-state
Time frame: Days 33 and 34
Cmax of ezogabine at steady state
Time frame: Days 10, 14, 18, 22, 26, 30, 33 and 34
Tmax of ezogabine at steady-state
Time frame: Days 10, 14, 18, 22, 26, 30, 33 and 34
Cmin of ezogabine at steady state
Time frame: Days 10, 14, 18, 22, 26, 30, 33 and 34
Cmax:Cmin Ratio of ezogabine
Time frame: Days 10, 14, 18, 22, 26, 30, 33 and 34
Fluctuation Index (FI) of ezogabine
Time frame: Days 10, 14, 18, 22, 26, 30, 33 and 34
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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GlaxoSmithKline