No effect on QT intervals of mipomersen, a 2′-O-methoxyethyl modified antisense oligonucleotide targeting ApoB-100 mRNA, in a phase i dose escalation placebo-controlled study, and confirmed by a thorough QT (tQT) study, in healthy subjects

European Journal of Clinical Pharmacology

Volumn 72, Issue 3, 2016, Pages 267-275

  Yu, Rosie Z ^a   Gunawan, Rudy ^a   Li, Zhaoyang ^b   Mittleman, Robert S ^b   Mahmood, Asif ^b   Grundy, John S ^a   Singleton, Walter ^a   Geary, Richard ^a   Wang, Yanfeng ^a  

^a ISIS PHARMACEUTICALS   (United States)

^b GENZYME CORPORATION   (United States)

Author keywords

Antisense oligonucleotide; Mipomersen; Phase I study; QT; tQT

Indexed keywords

APOLIPOPROTEIN B100; MESSENGER RNA; MIPOMERSEN; MOXIFLOXACIN; PLACEBO; ANTISENSE OLIGODEOXYNUCLEOTIDE; OLIGONUCLEOTIDE;

AREA UNDER THE CURVE; ARTICLE; CHRONOTHERAPY; CLINICAL EVALUATION; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; DRUG TARGETING; ELECTROCARDIOGRAM; HUMAN; HUMAN EXPERIMENT; MAXIMUM PLASMA CONCENTRATION; MULTIPLE DRUG DOSE; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; QT INTERVAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REPEATED DRUG DOSE; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; ADULT; BLOOD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG EFFECTS; ELECTROCARDIOGRAPHY; FEMALE; GENETICS; MALE; MIDDLE AGED; PHASE 1 CLINICAL TRIAL; YOUNG ADULT;

ADULT; APOLIPOPROTEIN B-100; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; ELECTROCARDIOGRAPHY; FEMALE; HEALTHY VOLUNTEERS; HUMANS; MALE; MIDDLE AGED; OLIGODEOXYRIBONUCLEOTIDES, ANTISENSE; OLIGONUCLEOTIDES; RNA, MESSENGER; YOUNG ADULT;

EID: 84958104510     PISSN: 00316970     EISSN: 14321041     Source Type: Journal    
DOI: 10.1007/s00228-015-1992-y     Document Type: Article

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