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P1‐294: Safety, tolerability, and pharmacokinetics of bi409306: A randomized, placebo‐controlled, double‐blinded phase i study in chinese and japanese healthy male volunteers
Author(s) -
Kim Jiyeong Maria,
Angela Yum Sun-Young,
Goetz Sophia,
Tsuda Yasuhiro,
Sand Michael,
Moschetti Viktoria,
Jang In-Jin
Publication year - 2015
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2015.06.495
Subject(s) - tolerability , medicine , placebo , adverse effect , pharmacokinetics , gastroenterology , pathology , alternative medicine
Smoking status, n (%) Never smoked 1 (12.5) 1 (20.0) 5 (83.3) 1 (14.3) 3 (50.0) 2 (28.6) 4 (66.7) 4 (80.0) 3 (50.0) 4 (66.7) 4 (66.7) 28 (45.2) Ex-smoker 1 (12.5) 1 (20.0) 1 (16.7) 1 (14.3) 0 (0.0) 2 (28.6) 2 (33.3) 1 (20.0) 2 (33.3) 1 (16.7) 1 (16.7) 12 (19.4) Currently smokes 6 (75.0) 3 (60.0) 0 (0.0) 5 (71.4) 3 (50.0) 3 (42.9) 0 (0.0) 0 (0.0) 1 (16.7) 1 (16.7) 1 (16.7) 22 (35.5) Alcohol status, n (%) Non-drinker 4 (50.0) 3 (60.0) 5 (83.3) 1 (14.3) 4 (66.7) 2 (28.6) 3 (50.0) 2 (40.0) 1 (16.7) 4 (66.7) 4 (66.7) 29 (46.8) Drinks, no interference 4 (50.0) 2 (40.0) 1 (16.7) 6 (85.7) 2 (33.3) 5 (71.4) 3 (50.0) 3 (60.0) 5 (83.3) 2 (33.3) 2 (33.3) 33 (53.2) Drinks, possible interference 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) *Treated set included all randomized subjects who received ≥1 dose of study medication. 1 Identical subjects consecutively received SD and MD treatment. BMI, body mass index; EM, extensive metabolizers; MD, multiple dose; PM, poor metabolizers; SD, single dose