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...
Date First Received: February 20, 2008
Last Updated: August 15, 2008
Verified by: GlaxoSmithKline, August 2008
Clinical Trial Phase: Phase 1 | Start Date: February 2008
Overall Status: Active, not recruiting
Estimated Enrollment: 119
Brief Summary
Official Title: “An Open-Label, Two-Cohort Study to Assess the Effect of Lamotrigine and Phenytoin on the Pharmacokinetics of Atorvastatin in Healthy Subjects”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Intervention(s) in this Clinical Trial
- Drug: lamotrigine
Outcome Measures for this Clinical Trial
Primary Measures
- 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 Measures
- 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.
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials Call Centre, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00627575
Study ID Number: LEP108937
ClinicalTrials.gov Identifier: NCT00627575
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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