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AED/Statin Interaction Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00627575
First Posted: March 3, 2008
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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. ]
    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. ]
    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
Actual Study Start Date: February 4, 2008
Study Completion Date: September 12, 2008
Primary Completion Date: September 12, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: lamotrigine
Lamotrigine tablets will be available in 25, 50, 100 and 200 mg dose strength.
Drug: atorvastatin
Atorvastatin will available as 40 mg tablets.
Active Comparator: 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.
Drug: atorvastatin
Atorvastatin will available as 40 mg tablets.
Drug: phenytoin
Phenytoin will available as 100 mg capsules.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: LEP108937
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: LEP108937
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: LEP108937
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: LEP108937
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: LEP108937
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: LEP108937
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: LEP108937
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00627575     History of Changes
Other Study ID Numbers: LEP108937
First Submitted: February 20, 2008
First Posted: March 3, 2008
Last Update Posted: August 4, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Keywords provided by GlaxoSmithKline:
drug interaction
pharmacokinetics
healthy volunteers

Additional relevant MeSH terms:
Atorvastatin Calcium
Lamotrigine
Anticonvulsants
Phenytoin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
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