A randomised phase 1 study to investigate safety, pharmacokinetics and impact on gut microbiota following single and multiple oral doses in healthy male subjects of SMT19969, a novel agent for Clostridium difficile infections

Table 1 Summary of dosing and group design for Parts 1 and 2 of the study

Part	Group (N)	SMT19969: Placebo	Dose and Interval	Dietary status	Subject numbers
1	A (4)	3:1	2 mg Single	Fasted	101 to 104
	B (4)	3:1	20 mg Single	Fasted	105 to 108
	C (8)	6:2	100 mg Single	Fasted	109 to 116
	D (8)	6:2	400 mg Single	Fasted	117 to 124
	E TP1 (8)	6:2	1,000 mg Single	Fasted	125 to 132
	E TP2 (8)	6:2	1,000 mg Single	Fed	125 to 132
	F (8)	6:2	2,000 mg Single	Fasted	133 to 140
2	G (8)	6:2	200 mg BID	Fed	201 to 208
2	H (8)	6:2	500 mg BID	Fed	209 to 216

Abbreviations: BID twice daily, N number of subjects studied, TP treatment period.

ISSN: 1471-2334