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No QTc Prolongation With Zanubrutinib: Results of Concentration-QTc Analysis From a Thorough QT Study in Healthy Subjects.

Mu S, Darpo B, Tang Z, Novotny W, Tawashi M, Xue H, Willett M, Lin L, Sahasranaman S, Ou YC.

Clin Transl Sci. 2020 Mar 7. doi: 10.1111/cts.12779. [Epub ahead of print]


Potential strategy for assessing QT/QTc interval for drugs that produce rapid changes in heart rate: Electrocardiographic assessment of the effects of intravenous remimazolam on cardiac repolarization.

Kleiman RB, Darpo B, Thorn M, Stoehr T, Schippers F.

Br J Clin Pharmacol. 2020 Mar 6. doi: 10.1111/bcp.14270. [Epub ahead of print]


Combination of olanzapine and samidorphan has no clinically relevant effects on ECG parameters, including the QTc interval: Results from a phase 1 QT/QTc study.

Sun L, Yagoda S, Xue H, Brown R, Nangia N, McDonnell D, Rege B, von Moltke L, Darpo B.

Prog Neuropsychopharmacol Biol Psychiatry. 2020 Jun 8;100:109881. doi: 10.1016/j.pnpbp.2020.109881. Epub 2020 Jan 28.


Intravenous Amisulpride Does Not Meaningfully Prolong the QTc Interval at Doses Effective for the Management of Postoperative Nausea and Vomiting.

Fox GM, Albayaty M, Walker JL, Xue H, Darpo B.

Anesth Analg. 2019 Dec 9. doi: 10.1213/ANE.0000000000004538. [Epub ahead of print]


Evaluation of Clinical Cardiac Safety of Itacitinib, a JAK1 Inhibitor, in Healthy Participants.

Gong X, Darpo B, Xue H, Punwani N, He K, Barbour AM, Epstein N, Landman R, Chen X, Yeleswaram S.

Clin Pharmacol Drug Dev. 2019 Dec 10. doi: 10.1002/cpdd.758. [Epub ahead of print]


Cardiac risk assessment based on early Phase I data and PK-QTc analysis is concordant with the outcome of thorough QTc trials: an assessment based on eleven drug candidates.

Gaitonde P, Huh Y, Darpo B, Ferber G, Heimann G, Li J, Lu K, Sebastien B, Tsai K, Riley S.

J Pharmacokinet Pharmacodyn. 2019 Dec;46(6):617-626. doi: 10.1007/s10928-019-09662-3. Epub 2019 Oct 30.


Effect of lofexidine on cardiac repolarization during treatment of opioid withdrawal.

Darpö B, Pirner M, Longstreth J, Ferber G.

Drug Alcohol Depend. 2019 Dec 1;205:107596. doi: 10.1016/j.drugalcdep.2019.107596. Epub 2019 Sep 27.


Revefenacin, a Long-Acting Muscarinic Antagonist, Does Not Prolong QT Interval in Healthy Subjects: Results of a Placebo- and Positive-Controlled Thorough QT Study.

Borin MT, Barnes CN, Darpo B, Pendyala S, Xue H, Bourdet DL.

Clin Pharmacol Drug Dev. 2020 Jan;9(1):130-139. doi: 10.1002/cpdd.732. Epub 2019 Aug 29.


Randomized, Double-Blind, Placebo- and Positive-Controlled Crossover Study of the Effects of Omadacycline on QT/QTc Intervals in Healthy Subjects.

Darpo B, Xue H, Tanaka SK, Tzanis E.

Antimicrob Agents Chemother. 2019 Sep 23;63(10). pii: e00922-19. doi: 10.1128/AAC.00922-19. Print 2019 Oct.


Evaluation of the Effect of 5 QT-Positive Drugs on the JTpeak Interval - An Analysis of ECGs From the IQ-CSRC Study.

Darpo B, Benson C, Brown R, Dota C, Ferber G, Ferry J, Jarugula V, Keirns J, Ortemann-Renon C, Pham T, Riley S, Sarapa N, Ticktin M, Zareba W, Couderc JP.

J Clin Pharmacol. 2020 Jan;60(1):125-139. doi: 10.1002/jcph.1502. Epub 2019 Aug 5.


CiPA challenges and opportunities from a non-clinical, clinical and regulatory perspectives. An overview of the safety pharmacology scientific discussion.

Wallis R, Benson C, Darpo B, Gintant G, Kanda Y, Prasad K, Strauss DG, Valentin JP.

J Pharmacol Toxicol Methods. 2018 Sep - Oct;93:15-25. doi: 10.1016/j.vascn.2018.06.005. Epub 2018 Jun 27. Review.


Challenges in implementing and obtaining acceptance for J-Tpeak assessment as the clinical component of CiPA.

Darpo B, Couderc JP.

J Pharmacol Toxicol Methods. 2018 Sep - Oct;93:75-79. doi: 10.1016/j.vascn.2018.05.006. Epub 2018 Jun 4.


Evaluating Potential QT Effects of JNJ-54861911, a BACE Inhibitor in Single- and Multiple-Ascending Dose Studies, and a Thorough QT Trial With Additional Retrospective Confirmation, Using Concentration-QTc Analysis.

Timmers M, Sinha V, Darpo B, Smith B, Brown R, Xue H, Ferber G, Streffer J, Russu A, Tritsmans L, Solanki B, Bogert J, Van Nueten L, Salvadore G, Nandy P.

J Clin Pharmacol. 2018 Jul;58(7):952-964. doi: 10.1002/jcph.1087. Epub 2018 Mar 5.


Study Design Parameters Affecting Exposure Response Analysis of QT Data: Results From Simulation Studies.

Ferber G, Sun Y, Darpo B, Garnett C, Liu J.

J Clin Pharmacol. 2018 May;58(5):674-685. doi: 10.1002/jcph.1065. Epub 2018 Feb 8.


Thorough QT/QTc Evaluation of the Cardiac Safety of Secnidazole at Therapeutic and Supratherapeutic Doses in Healthy Individuals.

Darpo B, Xue H, Adetoro N, Matthews BG, Pentikis HS.

J Clin Pharmacol. 2018 Mar;58(3):286-293. doi: 10.1002/jcph.1014. Epub 2017 Oct 2.


Effects of intranasal kinetic oscillation stimulation on heart rate variability.

Jerling M, Cygankiewicz I, Al-Tawil N, Darpo B, Ljungström A, Zareba W.

Ann Noninvasive Electrocardiol. 2018 Jan;23(1). doi: 10.1111/anec.12474. Epub 2017 Jun 7.


Ascending Single-Dose, Double-Blind, Placebo-Controlled Safety Study of Noribogaine in Opioid-Dependent Patients.

Glue P, Cape G, Tunnicliff D, Lockhart M, Lam F, Hung N, Hung CT, Harland S, Devane J, Crockett RS, Howes J, Darpo B, Zhou M, Weis H, Friedhoff L.

Clin Pharmacol Drug Dev. 2016 Nov;5(6):460-468. doi: 10.1002/cpdd.254. Epub 2016 Apr 1.


Solithromycin, a novel macrolide, does not prolong cardiac repolarization: a randomized, three-way crossover study in healthy subjects.

Darpo B, Sager PT, Fernandes P, Jamieson BD, Keedy K, Zhou M, Oldach D.

J Antimicrob Chemother. 2017 Feb;72(2):515-521. doi: 10.1093/jac/dkw428. Epub 2016 Oct 26.


Concentration-Response Modeling of ECG Data From Early-Phase Clinical Studies as an Alternative Clinical and Regulatory Approach to Assessing QT Risk - Experience From the Development Program of Lemborexant.

Murphy PJ, Yasuda S, Nakai K, Yoshinaga T, Hall N, Zhou M, Aluri J, Rege B, Moline M, Ferry J, Darpo B.

J Clin Pharmacol. 2017 Jan;57(1):96-104. doi: 10.1002/jcph.785. Epub 2016 Aug 4.


Can Bias Evaluation Provide Protection Against False-Negative Results in QT Studies Without a Positive Control Using Exposure-Response Analysis?

Ferber G, Zhou M, Dota C, Garnett C, Keirns J, Malik M, Stockbridge N, Darpo B.

J Clin Pharmacol. 2017 Jan;57(1):85-95. doi: 10.1002/jcph.779. Epub 2016 Jul 7.


Electrocardiographic Effects of a Supratherapeutic Dose of Oritavancin.

Mason JW, Bellibas SE, Huang NY, Sanabria CR, Darpo B.

Clin Pharmacol Drug Dev. 2016 Nov;5(6):502-508. doi: 10.1002/cpdd.268. Epub 2016 Jul 18.


Differentiating the Effect of an Opioid Agonist on Cardiac Repolarization From µ-Receptor-mediated, Indirect Effects on the QT Interval: A Randomized, 3-way Crossover Study in Healthy Subjects.

Darpo B, Zhou M, Bai SA, Ferber G, Xiang Q, Finn A.

Clin Ther. 2016 Feb;38(2):315-26. doi: 10.1016/j.clinthera.2015.12.004. Epub 2015 Dec 31.


Detection of ECG effects of (2R,4R)-monatin, a sweet flavored isomer of a component first identified in the root bark of the Sclerochitin ilicifolius plant.

Darpo B, Bjornsson TD, Brathwaite WA, Crincoli CM, Eapen AK, Fisher GL, Kowey PR, Miller MP, Nikiforov AI, Rihner MO, Zhou M.

Food Chem Toxicol. 2016 May;91:217-24. doi: 10.1016/j.fct.2015.12.023. Epub 2015 Dec 31.


Reduction over time of QTc prolongation in patients with sotalol after cardioversion of atrial fibrillation.

Lenhoff H, Darpö B, Ferber G, Rosenqvist M, Frick M.

Heart Rhythm. 2016 Mar;13(3):661-8. doi: 10.1016/j.hrthm.2015.11.040. Epub 2015 Dec 3.


Topic of Timely Interest-Decision Criteria for Negative QT Assessment Using Exposure Response Analysis of Data From Early-Phase Clinical Studies: Letter to the Editor.

Darpo B, Ferber G, Garnett C, Liu J, Stockbridge N.

Ther Innov Regul Sci. 2015 Sep;49(5):717-719. doi: 10.1177/2168479015596022. No abstract available.


Implications of the IQ-CSRC Prospective Study: Time to Revise ICH E14.

Darpo B, Garnett C, Keirns J, Stockbridge N.

Drug Saf. 2015 Sep;38(9):773-80. doi: 10.1007/s40264-015-0325-5.


Considerations for assessing the potential effects of antidiabetes drugs on cardiac ventricular repolarization: A report from the Cardiac Safety Research Consortium.

Heller S, Darpö B, Mitchell MI, Linnebjerg H, Leishman DJ, Mehrotra N, Zhu H, Koerner J, Fiszman ML, Balakrishnan S, Xiao S, Todaro TG, Hensley I, Guth BD, Michelson EL, Sager P.

Am Heart J. 2015 Jul;170(1):23-35. doi: 10.1016/j.ahj.2015.03.007. Epub 2015 Mar 18. Review.


Clinical ECG Assessment.

Darpo B.

Handb Exp Pharmacol. 2015;229:435-68. doi: 10.1007/978-3-662-46943-9_17. Review.


Evaluation of the QT effect of a combination of piperaquine and a novel anti-malarial drug candidate OZ439, for the treatment of uncomplicated malaria.

Darpo B, Ferber G, Siegl P, Laurijssens B, Macintyre F, Toovey S, Duparc S.

Br J Clin Pharmacol. 2015 Oct;80(4):706-15. doi: 10.1111/bcp.12680. Epub 2015 Jul 14.


Effect of ceralifimod (ONO-4641) on lymphocytes and cardiac function: Randomized, double-blind, placebo-controlled trial with an open-label fingolimod arm.

Krösser S, Wolna P, Fischer TZ, Boschert U, Stoltz R, Zhou M, Darpo B.

J Clin Pharmacol. 2015 Sep;55(9):1051-60. doi: 10.1002/jcph.513. Epub 2015 May 25.


A thorough QT study with dalbavancin: a novel lipoglycopeptide antibiotic for the treatment of acute bacterial skin and skin-structure infections.

Dunne MW, Zhou M, Darpo B.

Int J Antimicrob Agents. 2015 Apr;45(4):393-8. doi: 10.1016/j.ijantimicag.2014.12.021. Epub 2015 Jan 22.


Results from the IQ-CSRC prospective study support replacement of the thorough QT study by QT assessment in the early clinical phase.

Darpo B, Benson C, Dota C, Ferber G, Garnett C, Green CL, Jarugula V, Johannesen L, Keirns J, Krudys K, Liu J, Ortemann-Renon C, Riley S, Sarapa N, Smith B, Stoltz RR, Zhou M, Stockbridge N.

Clin Pharmacol Ther. 2015 Apr;97(4):326-35. doi: 10.1002/cpt.60.


A thorough QT study in the context of an uptitration regimen with selexipag, a selective oral prostacyclin receptor agonist.

Hoch M, Darpo B, Remenova T, Stoltz R, Zhou M, Kaufmann P, Bruderer S, Dingemanse J.

Drug Des Devel Ther. 2014 Dec 17;9:175-85. doi: 10.2147/DDDT.S75565. eCollection 2015.


Detection of QTc effects in small studies--implications for replacing the thorough QT study.

Ferber G, Zhou M, Darpo B.

Ann Noninvasive Electrocardiol. 2015 Jul;20(4):368-77. doi: 10.1111/anec.12227. Epub 2014 Nov 4.


Effect of ponesimod, a selective S1P1 receptor modulator, on the QT interval in healthy individuals.

Hoch M, Darpo B, Brossard P, Zhou M, Stoltz R, Dingemanse J.

Basic Clin Pharmacol Toxicol. 2015 May;116(5):429-37. doi: 10.1111/bcpt.12336. Epub 2014 Nov 8.


Safety, pharmacokinetics, pharmacogenomics and QT concentration-effect modelling of the SirT1 inhibitor selisistat in healthy volunteers.

Westerberg G, Chiesa JA, Andersen CA, Diamanti D, Magnoni L, Pollio G, Darpo B, Zhou M.

Br J Clin Pharmacol. 2015 Mar;79(3):477-91. doi: 10.1111/bcp.12513.


An exploratory double-blind, randomized clinical trial with selisistat, a SirT1 inhibitor, in patients with Huntington's disease.

Süssmuth SD, Haider S, Landwehrmeyer GB, Farmer R, Frost C, Tripepi G, Andersen CA, Di Bacco M, Lamanna C, Diodato E, Massai L, Diamanti D, Mori E, Magnoni L, Dreyhaupt J, Schiefele K, Craufurd D, Saft C, Rudzinska M, Ryglewicz D, Orth M, Brzozy S, Baran A, Pollio G, Andre R, Tabrizi SJ, Darpo B, Westerberg G; PADDINGTON Consortium.

Br J Clin Pharmacol. 2015 Mar;79(3):465-76. doi: 10.1111/bcp.12512.


Cardiac Safety Research Consortium: can the thorough QT/QTc study be replaced by early QT assessment in routine clinical pharmacology studies? Scientific update and a research proposal for a path forward.

Darpo B, Garnett C, Benson CT, Keirns J, Leishman D, Malik M, Mehrotra N, Prasad K, Riley S, Rodriguez I, Sager P, Sarapa N, Wallis R.

Am Heart J. 2014 Sep;168(3):262-72. doi: 10.1016/j.ahj.2014.06.003. Epub 2014 Jun 6.


Erratum to: Albiglutide Does Not Prolong QTc Interval in Healthy Subjects: A Thorough ECG Study.

Darpo B, Zhou M, Matthews J, Zhi H, Young MA, Perry C, Reinhardt RR.

Diabetes Ther. 2014 Dec;5(2):609. doi: 10.1007/s13300-014-0074-y. No abstract available.


Effect of lenvatinib (E7080) on the QTc interval: results from a thorough QT study in healthy volunteers.

Shumaker RC, Zhou M, Ren M, Fan J, Martinez G, Aluri J, Darpo B.

Cancer Chemother Pharmacol. 2014 Jun;73(6):1109-17.


Albiglutide Does Not Prolong QTc Interval in Healthy Subjects: A Thorough ECG Study.

Darpo B, Zhou M, Matthews J, Zhi H, Young MA, Perry C, Reinhardt RR.

Diabetes Ther. 2014 Jun;5(1):141-53. doi: 10.1007/s13300-014-0055-1. Epub 2014 Feb 8.


Importance of subject-specific QT/RR curvatures in the design of individual heart rate corrections of the QT interval.

Ferber G, Zhou M M, Darpo B.

J Electrocardiol. 2014 May-Jun;47(3):385-6. doi: 10.1016/j.jelectrocard.2013.12.010. Epub 2013 Dec 28. No abstract available.


The IQ-CSRC prospective clinical Phase 1 study: "Can early QT assessment using exposure response analysis replace the thorough QT study?".

Darpo B, Sarapa N, Garnett C, Benson C, Dota C, Ferber G, Jarugula V, Johannesen L, Keirns J, Krudys K, Ortemann-Renon C, Riley S, Rogers-Subramaniam D, Stockbridge N.

Ann Noninvasive Electrocardiol. 2014 Jan;19(1):70-81. doi: 10.1111/anec.12128. Epub 2013 Dec 30. Review.


Lomitapide at supratherapeutic plasma levels does not prolong the Qtc interval--results from a TQT study with moxifloxacin and ketoconazole.

Darpo B, Ferber G, Zhou M, Sumeray M, Sager P.

Ann Noninvasive Electrocardiol. 2013 Nov;18(6):577-89. doi: 10.1111/anec.12103. Epub 2013 Sep 30.


Are women more susceptible than men to drug-induced QT prolongation? Concentration-QTc modelling in a phase 1 study with oral rac-sotalol.

Darpo B, Karnad DR, Badilini F, Florian J, Garnett CE, Kothari S, Panicker GK, Sarapa N.

Br J Clin Pharmacol. 2014 Mar;77(3):522-31. doi: 10.1111/bcp.12201.


Assessment of the cardiac safety and pharmacokinetics of a short course, twice daily dose of orally-administered mifepristone in healthy male subjects.

Darpo B, Bullingham R, Combs DL, Ferber G, Hafez K.

Cardiol J. 2013;20(2):152-60. doi: 10.5603/CJ.2013.0028.


Early QT assessment--how can our confidence in the data be improved?

Darpo B, Garnett C.

Br J Clin Pharmacol. 2013 Nov;76(5):642-8. doi: 10.1111/bcp.12068. Review.


A phase I, open-label, single-arm study for QT assessment of eribulin mesylate in patients with advanced solid tumors.

Lesimple T, Edeline J, Carrothers TJ, Cvitkovic F, Darpo B, Delord JP, Léna H, Penel N, Edwards GJ, Law K, Wanders J, Kristensen A, Reyderman L.

Invest New Drugs. 2013 Aug;31(4):900-9. doi: 10.1007/s10637-012-9893-8. Epub 2012 Nov 11.


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