Eltrombopag does not affect cardiac repolarization: Results from a definitive QTc study in healthy subjects

British Journal of Clinical Pharmacology

Volumn 70, Issue 1, 2010, Pages 24-33

  Matthys, Gemma ^a   Park, Jung Wook ^a   McGuire, Sandra ^a   Wire, Mary Beth ^a   Zhang, Jianping ^a   Bowen, Carolyn ^a   Williams, Daphne ^a   Jenkins, Julian M ^a   Peng, Bin ^a  

^a GLAXOSMITHKLINE   (United States)

Author keywords

Eltrombopag; Promacta; QT interval; SB497115; Thrombopoietic

Indexed keywords

ELTROMBOPAG; MOXIFLOXACIN; PLACEBO;

ADULT; ADVERSE OUTCOME; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; ECG ABNORMALITY; EOSINOPHIL COUNT; FEMALE; GINGIVA PAIN; HEART REPOLARIZATION; HEART VENTRICLE EXTRASYSTOLE; HEART VENTRICLE TACHYCARDIA; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PRIORITY JOURNAL; QT INTERVAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; SECOND DEGREE ATRIOVENTRICULAR BLOCK; SIDE EFFECT; SINGLE DRUG DOSE; SINUS BRADYCARDIA; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TOOTH ABSCESS;

ADOLESCENT; ADULT; ANTI-INFECTIVE AGENTS; ARRHYTHMIAS, CARDIAC; AZA COMPOUNDS; BENZOIC ACIDS; DOSE-RESPONSE RELATIONSHIP, DRUG; ELECTROCARDIOGRAPHY; EPIDEMIOLOGIC METHODS; FEMALE; HEART RATE; HUMANS; HYDRAZINES; MALE; MIDDLE AGED; PYRAZOLES; QUINOLINES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77953520517     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2010.03646.x     Document Type: Article

References (12)

1. Erickson-Miller CL, Delorme E, Tian S-S, Hopson CB, Landis AJ, Valoret EI, Sellers TS, Rosen J, Miller SG, Luengo JI, Duffy KJ, Jenkins JM. Preclinical activity of eltrombopag (SB-497115), an oral, non-peptide thrombopoietin receptor agonist. Stem Cells 2009 27 : 424 430.
2. Jenkins JM, Williams D, Deng Y, Uhl J, Kitchen V, Collins D, Erickson-Miller CL. Phase 1 clinical study of eltrombopag, an oral, nonpeptide thrombopoietin receptor agonist. Blood 2007 109 : 4739 4741.
3. Bussel JB, Cheng G, Saleh MN, Psaila B, Kovaleva L, Meddeb B, Kloczko J, Hassani H, Mayer B, Stone NL, Arning M, Provan D, Jenkins JM. Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. N Engl J Med 2007 357 : 2237 2247.
4. McHutchison JG, Dusheiko G, Shiffman ML, Rodriguez-Torres M, Sigal S, Bourliere M, Berg T, Gordon SC, Campbell FM, Theodore D, Blackman N, Jenkins J, Afdhal NH, for the TPL102357 Study Group. Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. N Engl J Med 2007 357 : 2227 2236.
5. Fermini B, Fossa AA. The impact of drug-induced QT interval prolongation on drug discovery and development. Nat Rev Drug Discov 2003 2 : 439 447.
6. Roden DM. Drug-induced prolongation of the QT interval. N Engl J Med 2004 350 : 1013 1022.
7. Guidance for Industry. E14 clinical evaluation of QT/QTc interval prolongation and pro-arrhythmic potential for non-arrhythmic drugs. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. 2005.
8. Chow SC, Shao J, Wang H. Sample Size Calculations in Clinical Research.
9. GlaxoSmithKline. Promacta (eltrombopag) Tablets for Oral Use. Prescribing Information.
10. Sobotka PA, Mayer JH, Bauernfeind RA, Kanakis C, Rosen KM. Arrhythmias documented by 24 hour continuous ambulatory electrocardiographic monitoring in young women without apparent heart disease. Am Heart J 1981 101 : 753 759.
11. Brodsky M, Wu D, Denes P, Kanakis C, Rosen KM. Arrhythmias documented by 24 hour continuous electrocardiographic monitoring in 50 male medical students without apparent heart disease. Am J Cardiol 1977 39 : 390 395.
12. Viitasalo MT, Kala R, Eisalo A. Ambulatory electrocardiographic recording in endurance athletes. Br Heart J 1982 47 : 213 220.