AED/Statin Interaction Study

Phase 1

Completed

• Conditions: Epilepsy
• Interventions: Drug: lamotrigine; Drug: atorvastatin; Drug: phenytoin

• Registration Number: NCT00627575
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-04
• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-20
• Study First Posted: 2008-03-03
• Primary Completion: 2008-09-12
• Study Completion: 2008-09-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lamotrigine	atorvastatin	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	atorvastatin	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.
Lamotrigine	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.
phenytoin	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To assess the effect of lamotrigine or phenytoin on the pharmacokinetics of 2-OH atorvastatin and 4-OH atorvastatin	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.	Steady state Tmax, Cmax and AUC of 2-OH atorvastatin and 4-OH atorvastatin in the presence and absence of LTG XR or phenytoin.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Buffalo, New York, United States