AED/Statin Interaction Study

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Epilepsy

Treatments: Drug: phenytoin; Drug: atorvastatin; Drug: lamotrigine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00627575

LEP108937

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

Lamotrigine

Active Comparator group

Description:

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.

Treatment:

Drug: lamotrigine

Drug: atorvastatin

phenytoin

Active Comparator group

Description:

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.

Treatment:

Drug: atorvastatin

Drug: phenytoin