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 3 Summary of pharmacokinetic parameters following administration of SMT19969 in the fed state

	Mean (min – max) pharmacokinetic parameters
	Group E TP2	Group G		Group H
	1000 mg	200 mg BID		500 mg BID
	Day 1	Day 1	Day 10	Day 1	Day 10
	(N = 6)	(N = 1)	(N = 5)	(N = 4)	(N = 6)
AUC_0-tlast (ng.h/mL)	1.33 (0.706 – 3.46)	0.559 (N/A)	0.670 (0.524 – 1.30)	0.670 (0.531 – 1.23)	1.15 (0.515 – 1.98)
C_max(ng/mL)	0.211 (0.102 – 0.296)	0.120 (N/A)	0.141 (0.108 – 0.243)	0.148 (0.110 – 0.305)	0.177 (0.105 – 0.279)

Abbreviations: BID twice daily, AUC_0-tlast area under the plasma concentration-time curve from time zero up to the last quantifiable concentration, C_max maximum observed plasma concentration, N Number of subjects from which SMT19969 concentrations were quantifiable and could be included in calculation of PK parameters.

ISSN: 1471-2334