A randomized dose-escalation study to assess the safety, tolerability, and pharmacokinetics of ruxolitinib (INC424) in healthy Japanese volunteers

International Journal of Hematology

Volumn 97, Issue 3, 2013, Pages 351-359

  Ogama, Yoichiro ^a   Mineyama, Tomoko ^a   Yamamoto, Asuka ^a   Woo, Margaret ^b   Shimada, Naomi ^c   Amagasaki, Taro ^c   Natsume, Kazuto ^c  

^a Medical Co LTA Clinical Pharmacology Center   (Japan)

^b NOVARTIS PHARMA AG   (Switzerland)

^c NOVARTIS PHARMA K K   (Japan)

Author keywords

Clinical pharmacokinetics; Dose proportionality; Oral absorption; Race; Toxicity

Indexed keywords

ALANINE AMINOTRANSFERASE; CHOLESTEROL; INC 424; PLACEBO; RUXOLITINIB; UNCLASSIFIED DRUG; PYRAZOLE DERIVATIVE;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; AREA UNDER THE CURVE; ARTICLE; CHOLESTEROL BLOOD LEVEL; COHORT ANALYSIS; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; HUMAN; HYPERCHOLESTEROLEMIA; JAPANESE; LIMIT OF QUANTITATION; MALE; MAXIMUM PLASMA CONCENTRATION; MIDDLE AGED; NEUTROPHIL COUNT; NEUTROPHILIA; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SINGLE DRUG DOSE; UNSPECIFIED SIDE EFFECT; YOUNG ADULT; ASIAN; BLOOD; CONTROLLED CLINICAL TRIAL; HALF LIFE TIME; JAPAN; LEUKOCYTE COUNT; MYELOID METAPLASIA;

ADULT; ASIAN CONTINENTAL ANCESTRY GROUP; COHORT STUDIES; DOUBLE-BLIND METHOD; HALF-LIFE; HUMANS; JAPAN; LEUKOCYTE COUNT; MALE; MIDDLE AGED; PRIMARY MYELOFIBROSIS; PYRAZOLES;

EID: 84887582334     PISSN: 09255710     EISSN: 18653774     Source Type: Journal    
DOI: 10.1007/s12185-013-1280-5     Document Type: Article

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