AED/Statin Interaction Study - Tabular View

Tracking Information

First Received Date ^ICMJE

February 20, 2008

Last Updated Date

October 13, 2008

Start Date ^ICMJE

February 2008

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00627575 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

Drug: lamotrigine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

119

Completion Date

Primary Completion Date

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.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00627575

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

LEP108937

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

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