TABLE 1

Phase I study in healthy male subjects: summary of adverse events (AEs)

SRDMRD
PlaceboBI 1015550PlaceboBI 1015550
36 mg48 mgTotal6 mg twice daily12 mg twice dailyTotal
Number of subjects6 (100.0)6 (100.0)6 (100.0)12 (100.0)8 (100.0)8 (100.0)8 (100.0)16 (100.0)
Subjects with any AE1 (16.7)4 (66.7)4 (66.7)8 (66.7)3 (37.5)2 (25.0)5 (62.5)7 (43.8)
Subjects with investigator-defined drug-related AEs1 (16.7)2 (33.3)4 (66.7)6 (50.0)1 (12.5)2 (25.0)4 (50.0)6 (37.5)

Data are presented as n (%). SRD: single rising dose; MRD: multiple rising dose.