Impact of dosing regimen of custirsen, an antisense oligonucleotide, on safety, tolerability and cardiac repolarization in healthy subjects

British Journal of Clinical Pharmacology

Volumn 80, Issue 3, 2015, Pages 436-445

  Rabinovich Guilatt, Laura ^a   Elgart, Anna ^a   Erisson, Lavi ^b   Willsie, Sandra K ^c   Tessler, Shoshi ^a   Barnett Griness, Ofra ^a   Pande, Amitkumar ^a   Spiegelstein, Ofer ^a  

^a TEVA PHARMACEUTICALS   (Israel)

^b Codega Holdings LLC ^*  (United States)

^c PRA HEALTH SCIENCES   (United States)

Author keywords

antisense oligonucleotides; cardiac safety; custirsen; healthy subjects; pharmacokinetics; thorough QT

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; CREATINE KINASE; CUSTIRSEN; DEXAMETHASONE; GAMMA GLUTAMYLTRANSFERASE; PLACEBO; ANTIINFLAMMATORY AGENT; ANTINEOPLASTIC AGENT; ANTISENSE OLIGONUCLEOTIDE; NUCLEOTIDE; OGX-011;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; APPLICATION SITE EXCORIATION; ARTHRALGIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLURRED VISION; CHILL; CLINICAL PHARMACOLOGY; CONTACT DERMATITIS; CONTUSION; CREATINE KINASE BLOOD LEVEL; CROSSOVER PROCEDURE; DECREASED APPETITE; DIZZINESS; DRUG DOSE INCREASE; DRUG DOSE REGIMEN; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; ELECTROCARDIOGRAM; EYE PAIN; FATIGUE; FLUSHING; FOLLICULITIS; FOLLOW UP; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HEART REPOLARIZATION; HEMATURIA; HOT FLUSH; HUMAN; HYPERHIDROSIS; HYPERTRANSAMINASEMIA; INCIDENCE; INJECTION SITE EXTRAVASATION; INJECTION SITE REACTION; LYMPHOCYTE COUNT; MALE; MUSCLE SPASM; MYALGIA; NAUSEA; NORMAL HUMAN; PARESTHESIA; PARTIAL THROMBOPLASTIN TIME; PERSONAL EXPERIENCE; PHASE 1 CLINICAL TRIAL; PREMEDICATION; PRESYNCOPE; PRIORITY JOURNAL; SIDE EFFECT; VOMITING; ADOLESCENT; AMBULATORY ELECTROCARDIOGRAPHY; CHEMICALLY INDUCED; CLINICAL TRIAL; DOSE RESPONSE; DRUG EFFECTS; ELECTROCARDIOGRAPHY; INTRAVENOUS DRUG ADMINISTRATION; LONG QT SYNDROME; MAXIMUM TOLERATED DOSE; YOUNG ADULT;

ADOLESCENT; ADULT; ANTI-INFLAMMATORY AGENTS; ANTINEOPLASTIC AGENTS; CROSS-OVER STUDIES; DEXAMETHASONE; DOSE-RESPONSE RELATIONSHIP, DRUG; ELECTROCARDIOGRAPHY; ELECTROCARDIOGRAPHY, AMBULATORY; HEALTHY VOLUNTEERS; HUMANS; INFUSIONS, INTRAVENOUS; LONG QT SYNDROME; MALE; MAXIMUM TOLERATED DOSE; OLIGONUCLEOTIDES, ANTISENSE; PREMEDICATION; THIONUCLEOTIDES; YOUNG ADULT;

EID: 84940449590     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.12633     Document Type: Article

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