Effect of brivaracetam on cardiac repolarisation – a thorough QT study^*

References

• Kenda BM, Matagne AC, Talaga PE, et al. Discovery of 4-substituted pyrrolidone butanamides as new agents with significant antiepileptic activity. J Med Chem 2004;47:530–491. Kenda BM, Matagne AC, Talaga PE, et al. Discovery of 4-substituted pyrrolidone butanamides as new agents with significant antiepileptic activity. J Med Chem 2004;47:530–49
   PubMed Web of Science ®Google Scholar
• Lynch BA, Lambeng N, Nocka K, et al. The synaptic vesicle protein SV2A is the binding site for the antiepileptic drug levetiracetam. Proc Natl Acad Sci USA 2004;101:9861–62. Lynch BA, Lambeng N, Nocka K, et al. The synaptic vesicle protein SV2A is the binding site for the antiepileptic drug levetiracetam. Proc Natl Acad Sci USA 2004;101:9861–6
   PubMed Web of Science ®Google Scholar
• Matagne A, Margineanu DG, Kenda B, et al. Anti-convulsive and anti-epileptic properties of brivaracetam (ucb 34714), a high-affinity ligand for the synaptic vesicle protein, SV2A. Br J Pharmacol 2008 [published on line 26 May 2008, doi:10.1038/bjp.2008.198]3. Matagne A, Margineanu DG, Kenda B, et al. Anti-convulsive and anti-epileptic properties of brivaracetam (ucb 34714), a high-affinity ligand for the synaptic vesicle protein, SV2A. Br J Pharmacol 2008 [published on line 26 May 2008, doi:10.1038/bjp.2008.198]
   PubMed Web of Science ®Google Scholar
• Sargentini-Maier ML, Rolan P, Connell J, et al. The pharmacokinetics, CNS pharmacodynamics and adverse event profile of brivaracetam after single increasing oral doses in healthy males. Br J Clin Pharmacol 2007;63:680–84. Sargentini-Maier ML, Rolan P, Connell J, et al. The pharmacokinetics, CNS pharmacodynamics and adverse event profile of brivaracetam after single increasing oral doses in healthy males. Br J Clin Pharmacol 2007;63:680–8
   PubMed Web of Science ®Google Scholar
• Rolan P, Sargentini-Maier ML, Pigeolet E, et al. The pharmacokinetics, pharmacodynamics and adverse event profile of brivaracetam after multiple increasing oral doses in healthy males. Br J Clin Pharmacol 2008;66:71–55. Rolan P, Sargentini-Maier ML, Pigeolet E, et al. The pharmacokinetics, pharmacodynamics and adverse event profile of brivaracetam after multiple increasing oral doses in healthy males. Br J Clin Pharmacol 2008;66:71–5
   PubMed Web of Science ®Google Scholar
• Sargentini-Maier ML, Espié P, Coquette A, et al. Pharmacokinetics and metabolism of 14C–brivaracelam a noval SV2a ligand, in healthy subjects. Drug Metab Dispos 2008;36:36–456. Sargentini-Maier ML, Espié P, Coquette A, et al. Pharmacokinetics and metabolism of 14C–brivaracelam a noval SV2a ligand, in healthy subjects. Drug Metab Dispos 2008;36:36–45
   PubMed Web of Science ®Google Scholar
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. E14, Step 4; 2005. Available at: http://www.ich.org/LOB/media/MEDIA1476.pdf [last accessed on 17 January 2008]7. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. E14, Step 4; 2005. Available at: http://www.ich.org/LOB/media/MEDIA1476.pdf [last accessed on 17 January 2008]
   Google Scholar
• Morganroth J. Focus on issues in measuring and interpreting changes in the QTc interval duration. Eur Heart J 2001;3 Suppl K:K105–K1118. Morganroth J. Focus on issues in measuring and interpreting changes in the QTc interval duration. Eur Heart J 2001;3 Suppl K:K105–K111
   Web of Science ®Google Scholar
• Morganroth J. A definitive or thorough phase 1 QT ECG trial as a requirement for drug safety assessment. J Electrocardiol 2004;37:25–99. Morganroth J. A definitive or thorough phase 1 QT ECG trial as a requirement for drug safety assessment. J Electrocardiol 2004;37:25–9
   PubMed Web of Science ®Google Scholar
• Darpo B, Nebout T, Sager PT. Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 Guideline. J Clin Pharmacol 2006;46:498–50710. Darpo B, Nebout T, Sager PT. Clinical evaluation of QT/QTc prolongation and proarrhythmic potential for nonantiarrhythmic drugs: the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use E14 Guideline. J Clin Pharmacol 2006;46:498–507
   PubMed Web of Science ®Google Scholar
• Grisanti S, Morganroth J, Shah RR. A practical approach to cardiac safety: implementing ICH E14 to define cardiac safety in new drug development. Appl Clin Trials 2005; (Suppl October 2):10–1611. Grisanti S, Morganroth J, Shah RR. A practical approach to cardiac safety: implementing ICH E14 to define cardiac safety in new drug development. Appl Clin Trials 2005;(Suppl October 2):10–16
   Google Scholar
• Patterson SD; on behalf of Pharmaceutical Research and Manufacturers of America QT Statistics Expert Team. Investigating drug-induced QT and QTc prolongation in the clinic: a review of statistical design and analysis considerations. Drug Info J 2005;39:243–6612. Patterson SD; on behalf of Pharmaceutical Research and Manufacturers of America QT Statistics Expert Team. Investigating drug-induced QT and QTc prolongation in the clinic: a review of statistical design and analysis considerations. Drug Info J 2005;39:243–66
   Web of Science ®Google Scholar
• Malik M, Hnatkova K, Batchvarov V, et al. Sample size, power calculations, and their implications for the cost of thorough studies of drug induced QT interval prolongation. Pacing Clin Electrophysiol 2004;27:1659–6913. Malik M, Hnatkova K, Batchvarov V, et al. Sample size, power calculations, and their implications for the cost of thorough studies of drug induced QT interval prolongation. Pacing Clin Electrophysiol 2004;27:1659–69
   PubMed Web of Science ®Google Scholar
• Shah RR. Drugs, QTc interval prolongation and final ICH E14 guideline: an important milestone with challenges ahead. Drug Saf 2005;28:1009–2814. Shah RR. Drugs, QTc interval prolongation and final ICH E14 guideline: an important milestone with challenges ahead. Drug Saf 2005;28:1009–28
   PubMed Web of Science ®Google Scholar
• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guideline for good clinical practice. E6 (R1), Step 4, 1996. Available at: http://www.ich.org/LOB/media/MEDIA482.pdf [last accessed on 17 January 2008]15. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guideline for good clinical practice. E6 (R1), Step 4, 1996. Available at: http://www.ich.org/LOB/media/MEDIA482.pdf [last accessed on 17 January 2008]
   Google Scholar
• Williams GC, Dunnington KM, Hu MY, et al. The impact of posture on cardiac repolarisation: more than heart rate? J Cardiovasc Electrophysiol 2006;17:352–816. Williams GC, Dunnington KM, Hu MY, et al. The impact of posture on cardiac repolarisation: more than heart rate? J Cardiovasc Electrophysiol 2006;17:352–8
   Google Scholar
• Stass H, Dalhoff A, Kubitza D, et al. Pharmacokinetics, safety, and tolerability of ascending single doses of moxifloxacin, a new 8-methoxy quinolone, administered to healthy subjects. Antimicrob Agents Chemother 1998;42:2060–517. Stass H, Dalhoff A, Kubitza D, et al. Pharmacokinetics, safety, and tolerability of ascending single doses of moxifloxacin, a new 8-methoxy quinolone, administered to healthy subjects. Antimicrob Agents Chemother 1998;42:2060–5
   PubMed Web of Science ®Google Scholar
• Stass H, Wandel C, Delesen H, Moller JG. Effect of calcium supplements on the oral bioavailability of moxifloxacin in healthy male volunteers. Clin Pharmacokinet 2001;40 Suppl 1:27–3218. Stass H, Wandel C, Delesen H, Moller JG. Effect of calcium supplements on the oral bioavailability of moxifloxacin in healthy male volunteers. Clin Pharmacokinet 2001;40 Suppl 1:27–32
   PubMed Web of Science ®Google Scholar
• Sullivan JT, Woodruff M, Lettieri J, et al. Pharmacokinetics of a once-daily oral dose of moxifloxacin (Bay 12–8039), a new enantiomerically pure 8-methoxy quinolone. Antimicrob Agents Chemother 1999;43:2793–719. Sullivan JT, Woodruff M, Lettieri J, et al. Pharmacokinetics of a once-daily oral dose of moxifloxacin (Bay 12–8039), a new enantiomerically pure 8-methoxy quinolone. Antimicrob Agents Chemother 1999;43:2793–7
   PubMed Web of Science ®Google Scholar
• Shah RR, Morganroth J. Evaluating the QT-liability of a drug during its development. Pharm Med 2008;22:151–6420. Shah RR, Morganroth J. Evaluating the QT-liability of a drug during its development. Pharm Med 2008;22:151–64
   Google Scholar
• Noel GJ, Natarajan J, Chien S, et al. Effects of three fluoroquinolones on QT interval in healthy adults after single doses. Clin Pharmacol Ther 2003;73:292–30321. Noel GJ, Natarajan J, Chien S, et al. Effects of three fluoroquinolones on QT interval in healthy adults after single doses. Clin Pharmacol Ther 2003;73:292–303
   PubMed Web of Science ®Google Scholar
• Serra DB, Affrime MB, Bedigian MP, et al. QT and QTc interval with standard and supratherapeutic doses of darifenacin, a muscarinic M3 selective antagonist for the treatment of overactive bladder. J Clin Pharmacol 2005;45:1038–4722. Serra DB, Affrime MB, Bedigian MP, et al. QT and QTc interval with standard and supratherapeutic doses of darifenacin, a muscarinic M3 selective antagonist for the treatment of overactive bladder. J Clin Pharmacol 2005;45:1038–47
   PubMed Web of Science ®Google Scholar
• Skerjanec A, Affrime MB, Milosavljev S, et al. Darifenacin, an M3 selective receptor antagonist (M3 SRA), does not prolong QT/QTc. Clin Pharmacol Ther 2005;79:1023. Skerjanec A, Affrime MB, Milosavljev S, et al. Darifenacin, an M3 selective receptor antagonist (M3 SRA), does not prolong QT/QTc. Clin Pharmacol Ther 2005;79:10
   Google Scholar
• Hulhoven R, Rosillon D, Letiexhe M, et al. Levocetirizine does not prolong the QT/QTc interval in healthy subjects: results from a thorough QT study. Eur J Clin Pharmacol 2007;63:1011–724. Hulhoven R, Rosillon D, Letiexhe M, et al. Levocetirizine does not prolong the QT/QTc interval in healthy subjects: results from a thorough QT study. Eur J Clin Pharmacol 2007;63:1011–7
   PubMed Web of Science ®Google Scholar
• Malhotra BK, Glue P, Sweeney K, et al. Thorough QT study with recommended and supratherapeutic doses of tolterodine. Clin Pharmacol Ther 2007;81:377–8525. Malhotra BK, Glue P, Sweeney K, et al. Thorough QT study with recommended and supratherapeutic doses of tolterodine. Clin Pharmacol Ther 2007;81:377–85
   PubMed Web of Science ®Google Scholar
• Annegers JF, Coan SP. SUDEP: overview of definitions and review of incidence data. Seizure 1999;8:347–5226. Annegers JF, Coan SP. SUDEP: overview of definitions and review of incidence data. Seizure 1999;8:347–52
   PubMed Web of Science ®Google Scholar
• Ficker DM, So EL, Shen WK, et al. Population-based study of the incidence of sudden unexplained death in epilepsy. Neurology 1998;51:1270–427. Ficker DM, So EL, Shen WK, et al. Population-based study of the incidence of sudden unexplained death in epilepsy. Neurology 1998;51:1270–4
   PubMed Web of Science ®Google Scholar
• Yap YG, Camm AJ. Drug induced QT prolongation and torsades de pointes. Heart 2003;89:1363–7228. Yap YG, Camm AJ. Drug induced QT prolongation and torsades de pointes. Heart 2003;89:1363–72
   PubMed Web of Science ®Google Scholar
• Danielsson BR, Lansdell K, Patmore L, et al. Phenytoin and phenobarbital inhibit human HERG potassium channels. Epilepsy Res 2003;55:147–5729. Danielsson BR, Lansdell K, Patmore L, et al. Phenytoin and phenobarbital inhibit human HERG potassium channels. Epilepsy Res 2003;55:147–57
   PubMed Web of Science ®Google Scholar
• Danielsson BR, Lansdell K, Patmore L, et al. Effects of the antiepileptic drugs lamotrigine, topiramate and gabapentin on hERG potassium currents. Epilepsy Res 2005;63:17–2530. Danielsson BR, Lansdell K, Patmore L, et al. Effects of the antiepileptic drugs lamotrigine, topiramate and gabapentin on hERG potassium currents. Epilepsy Res 2005;63:17–25
   PubMed Web of Science ®Google Scholar
• Hulhoven R, Rosillon D, Bridson WE, et al. Effect of levetiracetam on cardiac repolarization in healthy subjects: a single-dose, randomised, placebo- and active-controlled, four-way crossover study. Clin Ther 2008;30:260–7031. Hulhoven R, Rosillon D, Bridson WE, et al. Effect of levetiracetam on cardiac repolarization in healthy subjects: a single-dose, randomised, placebo- and active-controlled, four-way crossover study. Clin Ther 2008;30:260–70
   PubMed Web of Science ®Google Scholar