AED/Statin Interaction Study

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627575
• Other study ID #: LEP108937
• Status: Completed
• Phase: Phase 1
• First received: February 20, 2008
• Last updated: August 2, 2017
• Start date: February 4, 2008
• Est. completion date: September 12, 2008

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: September 12, 2008
• Est. primary completion date: September 12, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• lamotrigine
Lamotrigine tablets will be available in 25, 50, 100 and 200 mg dose strength.
• atorvastatin
Atorvastatin will available as 40 mg tablets.
• phenytoin
Phenytoin will available as 100 mg capsules.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steady-state Cmax and AUC (0-t) of atorvastatin	Steady-state Cmax and AUC (0-t) of atorvastatin when dosed to steady-state.	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.
Secondary	To assess the effect of lamotrigine or phenytoin on the pharmacokinetics of 2-OH atorvastatin and 4-OH atorvastatin	Steady state Tmax, Cmax and AUC of 2-OH atorvastatin and 4-OH atorvastatin in the presence and absence of LTG XR or phenytoin.	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.

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study LEP108937 can be found on the GSK Clinical Study Register.