Effect of brivaracetam (400 mg/day) on the pharmacokinetics and pharmacodynamics of a combination oral contraceptive in healthy women

dc.contributor.authorStockis, A.
dc.contributor.authorRolan, P.
dc.date.issued2013
dc.description.abstractBrivaracetam is a high-affinity synaptic vesicle protein 2A ligand, in Phase III clinical development for epilepsy. This study assessed the effect of brivaracetam 400 mg/day on the pharmacokinetics and pharmacodynamics of a combination oral contraceptive (OC) containing 30 µg ethinylestradiol and 150 µg levonorgestrel, in healthy pre-menopausal women. This open-label, single-center, randomized, two-way crossover, multiple oral dose study (N01080) included two consecutive 28-day cycles without (control) or with brivaracetam (test), and a 28-day follow-up. OC was taken on Days 1–21 of every cycle and brivaracetam 200 mg twice daily was administered on Days 1–20 of the test cycle. Ethinylestradiol and levonorgestrel pharmacokinetics were determined on Day 20 and endogenous hormones were measured frequently during both control and test cycles. Overall, 23/24 participants (age: 19–39 years) completed the study. AUC ratio (90% confidence interval) for brivaracetam versus control was 0.73 (0.69, 0.78) for ethinylestradiol and 0.78 (0.72, 0.83) for levonorgestrel, outside pre-defined bioequivalence limits (0.80–1.25). Levels of endogenous hormones were similar and normal during brivaracetam and control cycles. Brivaracetam in combination with OC was well tolerated. Brivaracetam 400 mg/day co-administered with a combination OC in healthy women reduced ethinylestradiol and levonorgestrel plasma levels but did not result in ovulation.
dc.description.statementofresponsibilityArmel Stockis and Paul Rolan
dc.identifier.citationJournal of Clinical Pharmacology, 2013; 53(12):1313-1321
dc.identifier.doi10.1002/jcph.187
dc.identifier.issn1552-4604
dc.identifier.issn0091-2700
dc.identifier.urihttp://hdl.handle.net/2440/82669
dc.language.isoen
dc.publisherWiley-Blackwell Publishing, Inc
dc.rights© 2013, The American College of Clinical Pharmacology
dc.source.urihttps://doi.org/10.1002/jcph.187
dc.subjectCombination oral contraceptive
dc.subjectinteraction
dc.subjectbrivaracetam
dc.subjectpharmacokinetics
dc.subjectpharmacodynamics
dc.titleEffect of brivaracetam (400 mg/day) on the pharmacokinetics and pharmacodynamics of a combination oral contraceptive in healthy women
dc.typeJournal article
pubs.publication-statusPublished

Files