AED/Statin Interaction Study

NCT00627575 | Completed Phase 1

• 1 other identifier: LEP108937
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

drug interaction; pharmacokinetics; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

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.

Drug: lamotrigine; Drug: atorvastatin

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.

Drug: atorvastatin; Drug: phenytoin

Interventions

lamotrigine DRUG

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

Lamotrigine

atorvastatin DRUG

Atorvastatin will available as 40 mg tablets.

Lamotrigine; phenytoin

phenytoin DRUG

Phenytoin will available as 100 mg capsules.

phenytoin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body weight \>50kg (men) or \>45kg (women) and BMI within the range 19-32 kg/m2 inclusive.
• No clinically significant abnormality on clinical examination

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Buffalo, New York, 14202, United States

Location

Related Publications (1)

• 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.

  PMID: 21635243 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study LEP108937 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Epilepsy

Interventions

Lamotrigine; Atorvastatin; Phenytoin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids; Hydantoins; Imidazolidines; Imidazoles

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: March 3, 2008
• Study Start: February 4, 2008
• Primary Completion: September 12, 2008
• Study Completion: September 12, 2008
• Last Updated: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)