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AED/Statin Interaction Study

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: February 20, 2008
Last updated: May 31, 2012
Last verified: April 2011
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
Drug: lamotrigine
Drug: atorvastatin
Drug: phenytoin
Phase 1

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:

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 Drug: atorvastatin
Active Comparator: phenytoin Drug: atorvastatin Drug: phenytoin


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

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
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Please refer to this study by its identifier: NCT00627575

United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14202
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00627575     History of Changes
Other Study ID Numbers: LEP108937 
Study First Received: February 20, 2008
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
drug interaction
healthy volunteers

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Calcium Channel Blockers
Membrane Transport Modulators
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers processed this record on October 28, 2016