Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open-label, two-cohort study to assess the effect of lamotrigine and phenytoin on the pharmacokinetics of atorvastatin in healthy subjects
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Steady-state Cmax and AUC (0-t) of atorvastatin
Timeframe: 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 outcomes:
To assess the effect of lamotrigine or phenytoin on the pharmacokinetics of 2-OH atorvastatin and 4-OH atorvastatin
Timeframe: 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.
Interventions:
Drug: lamotrigine
Drug: atorvastatin
Drug: phenytoin
Enrollment:
119
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Bullman J, Nicholls A, Van Landringham K, Fleck R, Vuong A, Miller J, Alexander S, Messenheimer J. Effects of Lamotrigine XR and Phenytoin on the Pharmacokinetics of Atorvastatin in Healthy Volunteers. Epilepsia. 2011;52(7):1351-1358.
Medical condition
Epilepsy
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
February 2008 to September 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Body weight >50kg (men) or >45kg (women) and BMI within the range 19-32 kg/m2 inclusive.
- No clinically significant abnormality on clinical examination
- History or evidence of drug or alcohol abuse or active tobacco use.
- Women of childbearing potential
Inclusion and exclusion criteria
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
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.
Trial location(s)
Location
GSK Investigational Site
Buffalo, New York, United States, 14202
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-12-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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