Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the amount of the cholesterol-lowering drug atorvastatin available in the bloodstream, when taken together with the anti-seizure drugs lamotrigine or phenytoin.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lamotrigine | Active Comparator | Subjects will receive 40 milligram (mg) of Atrovastatin from Days 1-7, from Days 8-56 subjects will receive Lamotrigine and Subjects will receive 300 mg/day of Lamotrigine and 40 mg/day of atorvastatin each morning on Days 57-77. |
|
| phenytoin | Active Comparator | Subjects will receive 40 mg of Atrovastatin from Days 1-7, from Days 8-28, subjects will receive 4mg/kg/day of phenytoin in the morning and will continue to take 40 mg/day of atorvastatin each morning. Subjects will receive taper dose of phenytoin from Days 29-30. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lamotrigine | Drug | Lamotrigine tablets will be available in 25, 50, 100 and 200 mg dose strength. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Steady-state Cmax and AUC (0-t) of atorvastatin | Steady-state Cmax and AUC (0-t) of atorvastatin when dosed to steady-state. | Pre-dose,0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hrs post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of lamotrigine or phenytoin on the pharmacokinetics of 2-OH atorvastatin and 4-OH atorvastatin | Steady state Tmax, Cmax and AUC of 2-OH atorvastatin and 4-OH atorvastatin in the presence and absence of LTG XR or phenytoin. | Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hrs post dose. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Buffalo | New York | 14202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21635243 | Background | Bullman J, Nicholls A, Van Landingham K, Fleck R, Vuong A, Miller J, Alexander S, Messenheimer J. Effects of lamotrigine and phenytoin on the pharmacokinetics of atorvastatin in healthy volunteers. Epilepsia. 2011 Jul;52(7):1351-8. doi: 10.1111/j.1528-1167.2011.03118.x. Epub 2011 Jun 2. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| LEP108937 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077213 | Lamotrigine |
| D000069059 | Atorvastatin |
| D010672 | Phenytoin |
| ID | Term |
|---|---|
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| atorvastatin | Drug | Atorvastatin will available as 40 mg tablets. |
|
| phenytoin | Drug | Phenytoin will available as 100 mg capsules. |
|
| Results for study LEP108937 can be found on the GSK Clinical Study Register. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| LEP108937 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LEP108937 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LEP108937 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LEP108937 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LEP108937 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LEP108937 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D001393 |
| Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |