Pharmacokinetics of surotomycin from phase 1 single and multiple ascending dose studies in healthy volunteers

Table 3 Treatment-emergent AEs by system organ class and preferred term (safety population). Observed in ≥2 subjects in the a) SAD and b) MAD study

System organ class Preferred term	Single ascending dose
System organ class Preferred term	500 mg (n = 8) n (%)	1000 mg (n = 8) n (%)	2000 mg (n = 8) n (%)	4000 mg (n = 8) n (%)	Placebo (n = 8) n (%)
At least one TEAE	3 (37.5)	0	5 (62.5)	3 (37.5)	2 (25.0)
Gastrointestinal disorders	2 (25.0)	0	3 (37.5)	1 (12.5)	1 (12.5)
Diarrhea	1 (12.5)	0	3 (37.5)	1 (12.5)	0
Infections and infestations	0	0	0	2 (25.0)	0
Investigations	0	0	1 (12.5)	1 (12.5)	0
Transaminase increased	0	0	1 (12.5)	1 (12.5)	0
System organ class Preferred term	Multiple ascending dose
System organ class Preferred term	250 mg BID (n = 8) n (%)	500 mg BID (n = 8) n (%)	1000 mg BID (n = 8) n (%)	Placebo (n = 6) n (%)
At least one TEAE	4 (50.0)	6 (75.0)	5 (62.5)	3 (50.0)
Nervous system disorders	2 (25.0)	1 (12.5)	2 (25.0)	2 (33.3)
Headache	1 (12.5)	1 (12.5)	0	2 (33.3)
Gastrointestinal disorders	2 (25.0)	0	2 (25.0)	3 (50.0)
Respiratory, thoracic, and mediastinal disorders	0	2 (25.0)	2 (25.0)	0
Oropharyngeal pain	0	1 (12.5)	1 (12.5)	0
General disorders and administration- site conditions	0	0	2 (25.0)	1 (16.7)
Infections and infestations	0	1 (12.5)	1 (12.5)	0
Musculoskeletal and connective tissue disorders	2 (25.0)	2 (25.0)	0	0
Back pain	1 (12.5)	1 (12.5)	0	0
Skin and subcutaneous tissue disorders	0	1 (12.5)	1 (12.5)	0
Pruritus	0	1 (12.5)	1 (12.5)	0

BID Twice daily, MAD multiple ascending oral dose; SAD single ascending dose; TEAE Treatment-emergent adverse advent

ISSN: 2050-6511