Single- and multiple-ascending dose studies to evaluate the safety, tolerability, and pharmacokinetics of daclatasvir and asunaprevir in healthy male Japanese subjects

International Journal of Clinical Pharmacology and Therapeutics

Volumn 53, Issue 4, 2015, Pages 292-300

  Shiozaki, Tomomi ^a   Ueno, Takayo ^a   Nagashima, Hirotaka ^b   Yamahira, Naomi ^a   Hiraoka, Masaki ^a   Eley, Tim ^c   Bifano, Marc ^c   Bertz, Richard J ^c  

^a Bristol Myers KK   (Japan)

^b Tokyo Clinical Research Center   (Japan)

^c BRISTOL MYERS SQUIBB   (United States)

Author keywords

Antiviral; Asunaprevir; Daclatasvir; Healthy; Hepatitis C; Japanese; Pharmacokinetic

Indexed keywords

ASUNAPREVIR; DACLATASVIR; PLACEBO; ANTIVIRUS AGENT; BMS-790052; IMIDAZOLE DERIVATIVE; ISOQUINOLINE DERIVATIVE; SULFONAMIDE;

ADULT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DOSE INCREASE; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; DRUG WITHDRAWAL; HUMAN; HUMAN EXPERIMENT; JAPANESE (PEOPLE); MALE; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; UNSPECIFIED SIDE EFFECT; ASIAN CONTINENTAL ANCESTRY GROUP; BIOLOGICAL MODEL; BLOOD; CLINICAL TRIAL; DRUG ADMINISTRATION; MIDDLE AGED; ORAL DRUG ADMINISTRATION; YOUNG ADULT;

ADMINISTRATION, ORAL; ADULT; ANTIVIRAL AGENTS; ASIAN CONTINENTAL ANCESTRY GROUP; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; HEALTHY VOLUNTEERS; HUMANS; IMIDAZOLES; ISOQUINOLINES; MALE; MIDDLE AGED; MODELS, BIOLOGICAL; SULFONAMIDES; YOUNG ADULT;

EID: 84929453748     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CP202186     Document Type: Article

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