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Egdb1de1.Pdf 1 2 A todos los que me han dado la fuerza y la ilusión para llegar aquí A mis padres, hermanas y Ricard, por su cariño, sus cuidados y su ejemplo, sin vosotros no hubiese sido posible. A Iñaki, porque cuando te fuiste, te llevaste parte de mi vida, pero lo vivido me acompañará siempre, y tu recuerdo me ayuda a ser mejor. 3 4 EVALUATION OF CARDIOTOXICITY OF RUPATADINE, AN ANTIHISTAMINE, AS RECOMMENDED BY THE ICH E14 AIMS: To evaluate the effects of therapeutic and supratherapeutic doses of rupatadine on cardiac repolarization in line with a 'thorough QT/QTc study' protocol performed according to International Conference on Harmonization guidelines. METHODS: This was a randomized (gender-balanced), parallel-group study involving 160 healthy volunteers. Rupatadine, 10 and 100 mg od, and placebo were administered single- blind for 5 days, whilst moxifloxacin 400 mg/day was given on days 1 and 5 in open- label fashion. ECGs were recorded over a 23-h period by continuous Holter monitoring at baseline and on treatment days 1 and 5. Three 10-s ECG samples were downloaded at regular intervals and were analysed independently. The primary analysis of QTc was based on individually corrected QT (QTcI). Treatment effects on QTcI were assessed using the largest time-matched mean difference between the drug and placebo (baseline-subtracted) for the QTcI interval. A negative 'thorough QT/QTc study' is one where the main variable is around < or =5 ms, with a one-sided 95% confidence interval that excludes an effect >10 ms. RESULTS: The validity of the trial was confirmed by the fact that the moxifloxacin-positive control group produced the expected change in QTcI duration (around 5 ms). The ECG data for rupatadine at both 10 and 100 mg showed no signal effects on the ECG, after neither single nor repeated administration. Furthermore, no pharmacokinetic/pharmacodynamic relationship, gender effects or clinically relevant changes in ECG waveform outliers were observed. No deaths or serious or unexpected adverse events were reported. CONCLUSIONS: This 'thorough QT/QTc study' confirmed previous experience with rupatadine and demonstrated that it had no proarrhythmic potential and raised no concerns regarding its cardiac safety. 5 6 INDEX ! 1.1 An overview of the drug discovery and development process! =1=1= &)*!$%"#(%&$''111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111=C =1=1> &!#!(&!'111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111=D =1=1? !#!(&!'11111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111>< =1=1@ $!$&)!($&-)($&('0)&$%# #'#-11111111111111111111111111111111111111111111111>A 1.2 Cardiac safety in drug development$ =1>1= '($&-$&)#)6'-#&$"111111111111111111111111111111111111111111111111111111111111111111111111111111111>D =1>1> !(&$%-'$!$-$&(*(-111111111111111111111111111111111111111111111111111111111111111111111111111111111111?< =1>1? $!$!(&!(*(-#!$##(&*!#1111111111111111111111111111111111111111111111111111111111?B =1>1@ &)#)%&$!$#($#111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111@@ =1>1@1= #(&&-("&)'11111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111@B =1>1@1> #('("#'111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111@C =1>1@1? #("&$!'1111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111@D =1>1@1@ &-!#(%&''#('111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111@E =1>1@1A )&$!%('1111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111A< =1>1@1B &$ #('111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111A= =1>1@1C (&%&$!$##&)'11111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111A> =1>1A (&&' ($&'($(&&$&'%$#('111111111111111111111111111111111111111111111111111111111111111111A? =1>1A1= #(*&($#'1111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111A? =1>1A1> $"#11111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111A? =1>1A1? &-&11111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111A@ =1>1A1@ -%$ !"111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111AA =1>1A1A (&!&!!($#$#*&'$#111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111AA =1>1A1B &) ($!'"11111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111AB =1>1B &!#!&'(-*!)($#1111111111111111111111111111111111111111111111111111111111111111111111111111111111111AE =1>1B1= In Vitro &''-1111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111B> =1>1B1> In Vivo''-111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111BA =1>1B1? #(&(&' ''''"#(11111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111BB =1>1C !#!&'(-*!)($#111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111BC =1>1C1= (*$(3($&$)54'()-1111111111111111111111111111111111111111111111111111111111111111111111111111111C= =1>1C1> )('#!)'$##(3($&$)54'()-111111111111111111111111111111111111111111111111111111111111111111C= =1>1C1? ()-'#$(3($&$)54'()-11111111111111111111111111111111111111111111111111111111111111111111111111C> =1>1C1@ (('(!'')'$&(3($&$)54'()-1111111111111111111111111111111111111111111111111111111111111111111D? =1>1C1A #(&%&(($#$(3($&$)54'()-111111111111111111111111111111111111111111111111111111111111111111111111DE =1>1C1B 3($&$)54'()-2'"%($#!#!%&$&"11111111111111111111111111111111111111111111111111111DE 1.3 Rupatadine: Development of a novel antihistamine% =1?1= &$!"'(("#(111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111E= =1?1=1=!!&&#('1111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111E= =1?1=1>&$#$%()&(&111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111E? =1?1> #('("#'/(&%)($%($#11111111111111111111111111111111111111111111111111111111111111111111111111111111111E@ =1?1? &$)((&%)(&($#!1111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111EB =1?1@ *!$%"#(%&$&""1111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111EC =1?1@1= )!(-'%('111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111ED =1?1@1> $#!#!'()'11111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111ED =1?1@1? !#!'()'1111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111=<@ 7 2.1 Primary endpoint 2.2 Secondary endpointss 3.1 Ethics ?1=1= #%##(('$""((8 911111111111111111111111111111111111111111111111111111111111111111111111111111111111111==? ?1=1> (!$#)($('()-11111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111==? ?1=1? 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