Table 5.

Geometric mean pharmacokinetic parameters (A) and evaluation of food effect (B) for the prodrug and OBE002 in plasma

A. Geometric mean pharmacokinetic parameters
		Geometric means of Prodrug			Geometric means of OBE002
Parameter (unit)		Prodrug	Prodrug	Prodrug	Prodrug	Prodrug	Prodrug
		100 mg	300 mg	1000 mg	100 mg	300 mg	1000 mg
		N = 6	N = 6	N = 6	N = 6	N = 6	N = 6
C max (ng ml –1 )	Fed / Fasted	0.69	0.59	4.53	26.8	100.5	567.2
		0.20	0.85	3.10	31.3	142.2	671.6
AUC 0–24h (h × ng ml –1 )	Fed / Fasted	0.36a	1.53	9.83	313.0	1079.1	6411.2
		0.13b	1.43	6.06	232.8	1052.7	5267.1
AUC 0–t (h × ng ml –1 )	Fed / Fasted	0.36a	1.53	9.83	335.9	1201.7	6874
		0.13b	1.43	6.06	232.8	1052.7	5267.1
AUC 0–inf (h × ng ml –1 )	Fed / Fasted	1.47c	2.38d	10.67	402.5d	1579.5d	8059.3
		‐	1.56b	6.39	316.3	1559.1	7177.7

B. Evaluation of food effect
	Prodrug (fed vs. fasted)			OBE002 (fed vs. fasted)
Parameter	No. of subjects/observations	Estimate	90% CI	No. of subjects/ observations		Estimate	90% CI
C max	17/28	1.20	0.75–1.92	17/34		0.80	0.68–0.94
AUC 0–24h	17/28	1.55	0.98–2.44	17/34		1.06	0.95–1.18
AUC 0–t	17/28	1.55	0.98–2.44	17/34		1.06	0.95–1.18
AUC 0–inf	17/20	1.84	1.55–2.17	17/32		1.15	1.07–1.24

N = number of subjects in cohort;

^aFour missing values;

^bTwo missing values;

^cFive missing values;

^dOne missing value;

CI = confidence interval