AED/Statin Interaction Study

Verified by: GlaxoSmithKline, April 2011
First Received: February 20, 2008 | Last Updated: April 21, 2011 | Phase: Phase 1 | Start Date: February 2008
Overall Status: Completed | Estimated Enrollment: 119
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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...

Brief Summary

Official Title: “An Open-label, Two-cohort Study to Assess the Effect of Lamotrigine and Phenytoin on the Pharmacokinetics of Atorvastatin in Healthy Subjects”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

  • Drug: lamotrigine
  • Drug: atorvastatin
  • Drug: phenytoin

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Lamotrigine
  • Active Comparator: phenytoin

Outcome Measures for this Clinical Trial

Primary 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.
      Safety Issue?: No

Secondary 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.
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00627575

Study ID Number: LEP108937

ClinicalTrials.gov Identifier: NCT00627575

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00627575