AED/Statin Interaction Study - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00627575

Purpose

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.

Condition	Intervention	Phase
Epilepsy	Drug: lamotrigine	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Official Title:	An Open-Label, Two-Cohort Study to Assess the Effect of Lamotrigine and Phenytoin on the Pharmacokinetics of Atorvastatin in Healthy Subjects

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Steady-state maximum and total concentration of atorvastatin in the presence and absence of lamotrigine or phenytoin at dosing, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24hrs post dose.

Secondary Outcome Measures:

Steady-state maximum and total concentration of the active metabolites of atorvastatin in the presence and absence of lamotrigine or phenytoin at dosing, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24hrs post dose.

Estimated Enrollment:	119
Study Start Date:	February 2008

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627575

Locations

United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14202

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	LEP108937
Study First Received:	February 20, 2008
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00627575 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

healthy volunteers
drug interaction
pharmacokinetics

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Central Nervous System Diseases
Calcium Channel Blockers
Cardiovascular Agents
Brain Diseases
Pharmacologic Actions

Membrane Transport Modulators
Epilepsy
Therapeutic Uses
Lamotrigine
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010