Safety, tolerability, and pharmacokinetics of bi409306: A randomized, placebo-controlled, double-blinded phase i study in chinese and japanese healthy male volunteers

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