Malaria Research and Treatment

Clinical Study

Single Ascending Dose Safety and Pharmacokinetics of CDRI-97/78: First-in-Human Study of a Novel Antimalarial Drug

Table 4

Comparison of liver function tests between various treatment groups on repeated observations at baseline, 24 hours and day 7.


Treatment groups	Total serum bilirubin			Serum SGOT			Serum SGPT			Serum Alkaline phosphatase
Treatment groups	Baseline	24 hour	Day 7	Baseline	24 hour	Day 7	Baseline	24 hour	Day 7	Baseline	24 hour	Day 7

80 mg ()
160 mg ()
320 mg ()
400 mg ()
500 mg ()
600 mg ()
700 mg ()
Placebo ()

ANOVA
	1.114	1.308	1.105	1.701	1.631	1.14	1.62	1.097	1.435	4.545	5.103	3.802
df	49	49	49	49	49	49	49	49	49	49	49	49
	0.37	0.27	0.38	0.13	0.15	0.36	0.16	0.38	0.22	<0.001*	<0.001**	0.002^#

for 500 mg compared to 80 mg drug and for 600 mg compared to 80 mg drug (Scheffe’s test); and 0.006 for 80 mg drug compared to 500 and 600 mg drug respectively (Scheffe’s test). ^# for comparison between 80 and 500 mg drug groups (Scheffe’s test). No difference from placebo in any comparison.