AED/Statin Interaction Study
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: lamotrigine (Drug); atorvastatin (Drug); phenytoin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, 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: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Steady-state Cmax and AUC (0-t) of atorvastatin
Secondary outcome: To assess the effect of lamotrigine or phenytoin on the pharmacokinetics of 2-OH atorvastatin and 4-OH atorvastatin
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 Investigational Site, Buffalo, New York 14202, United States
Additional Information
Starting date: February 2008
Last updated: May 31, 2012
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