AED/Statin Interaction Study

GlaxoSmithKline119 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

119

Conditions

Epilepsy

Interventions

lamotrigineDRUG

Lamotrigine tablets will be available in 25, 50, 100 and 200 mg dose strength.

atorvastatinDRUG

Atorvastatin will available as 40 mg tablets.

phenytoinDRUG

Phenytoin will available as 100 mg capsules.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: * Body weight \>50kg (men) or \>45kg (women) and BMI within the range 19-32 kg/m2 inclusive. * No clinically significant abnormality on clinical examination Key Exclusion Criteria: * History or evidence of drug or alcohol abuse or active tobacco use. * Women of childbearing potential * Use of prescribed or non-prescribed medications during and within 14 days of starting study medication.

Locations (1)

GSK Investigational Site

Buffalo, New York, United States

Outcomes

Primary Outcomes

Steady-state Cmax and AUC (0-t) of atorvastatin

Steady-state Cmax and AUC (0-t) of atorvastatin when dosed to steady-state.

Time frame: 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.

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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