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 Drug: atorvastatin Drug: phenytoin	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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: Drug Reactions Epilepsy Statins

Drug Information available for: Phenytoin Lamotrigine Atorvastatin Atorvastatin calcium Phenytoin sodium

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Steady-state Cmax and AUC (0-t) of atorvastatin [ Time Frame: 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. ] [ Designated as safety issue: No ]
Steady-state Cmax and AUC (0-t) of atorvastatin when dosed to steady-state.

Secondary Outcome Measures:

To assess the effect of lamotrigine or phenytoin on the pharmacokinetics of 2-OH atorvastatin and 4-OH atorvastatin [ Time Frame: 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. ] [ Designated as safety issue: No ]
Steady state Tmax, Cmax and AUC of 2-OH atorvastatin and 4-OH atorvastatin in the presence and absence of LTG XR or phenytoin.

Enrollment:	119
Study Start Date:	February 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Lamotrigine	Drug: lamotrigine Other Name: lamotrigine Drug: atorvastatin Other Name: atorvastatin
Active Comparator: phenytoin	Drug: atorvastatin Other Name: atorvastatin Drug: phenytoin Other Name: phenytoin

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:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00627575 History of Changes
Other Study ID Numbers:	LEP108937
Study First Received:	February 20, 2008
Last Updated:	April 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

drug interaction
pharmacokinetics
healthy volunteers

Additional relevant MeSH terms:

Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lamotrigine
Phenytoin
Atorvastatin
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on February 09, 2012