AED/Statin Interaction Study
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: lamotrigine (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials Call Centre, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: An Open-Label, Two-Cohort Study to Assess the Effect of Lamotrigine and Phenytoin on the Pharmacokinetics of Atorvastatin in Healthy Subjects
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Primary outcome: 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.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Buffalo, New York 14202, United States; Not yet recruiting
Charles Ballow, Phone: 877-379-3718
Additional Information
Starting date: February 2008
Last updated: February 20, 2008
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