AED/Statin Interaction Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-04

Study Completion Date

2008-09-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lamotrigine

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.

Group Type ACTIVE_COMPARATOR

lamotrigine

Intervention Type DRUG

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

atorvastatin

Intervention Type DRUG

Atorvastatin will available as 40 mg tablets.

phenytoin

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.

Group Type ACTIVE_COMPARATOR

atorvastatin

Intervention Type DRUG

Atorvastatin will available as 40 mg tablets.

phenytoin

Intervention Type DRUG

Phenytoin will available as 100 mg capsules.

Interventions

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lamotrigine

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

Intervention Type DRUG

atorvastatin

Atorvastatin will available as 40 mg tablets.

Intervention Type DRUG

phenytoin

Phenytoin will available as 100 mg capsules.

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Buffalo, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 21635243 (View on PubMed)

Study Documents

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