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AED/Statin Interaction Study

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ClinicalTrials.gov Identifier: NCT00627575
Recruitment Status : Completed
First Posted : March 3, 2008
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE February 20, 2008
First Posted Date  ICMJE March 3, 2008
Last Update Posted Date August 4, 2017
Actual Study Start Date  ICMJE February 4, 2008
Actual Primary Completion Date September 12, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2008)
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.
Change History Complete list of historical versions of study NCT00627575 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2011)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2008)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AED/Statin Interaction Study
Official Title  ICMJE An Open-label, Two-cohort Study to Assess the Effect of Lamotrigine and Phenytoin on the Pharmacokinetics of Atorvastatin in Healthy Subjects
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • 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.
  • Drug: phenytoin
    Phenytoin will available as 100 mg capsules.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: lamotrigine
    • Drug: atorvastatin
  • 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.
    Interventions:
    • Drug: atorvastatin
    • Drug: phenytoin
Publications * Bullman J, Nicholls A, Van Landingham K, Fleck R, Vuong A, Miller J, Alexander S, Messenheimer J. Effects of lamotrigine and phenytoin on the pharmacokinetics of atorvastatin in healthy volunteers. Epilepsia. 2011 Jul;52(7):1351-8. doi: 10.1111/j.1528-1167.2011.03118.x. Epub 2011 Jun 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2008)
119
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 12, 2008
Actual Primary Completion Date September 12, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00627575
Other Study ID Numbers  ICMJE LEP108937
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP