Table 7.

Steady-state plasma PK profiles for ALZ-801 (prodrug) and tramiprosate (active drug) after oral administration of ALZ-801 (tablet) 265 mg twice daily over 7 days in fed healthy human subjects in the phase I multiple ascending dose study (i.e. Cohort D of Study 2 in Table 1; n = 9)

Food status	Plasma analyte	Day	T max (h)	C max (ng/mL)	AUC12 (ng/mL h)	AUC24 (ng/mL h)	t ½ (h)
Fed	ALZ-801	1	2.448 ± 0.848	4960 ± 2650	10,300 ± 2830	10,300 ± 2830	1.05 ± 0.160
	Tramiprosate	1	3.559 ± 0.880	759 ± 163	3300 ± 608	3650 ± 670	8.94 ± 1.35
Fed	ALZ-801	7	2.114 ± 0.553	6460 ± 1800	11,200 ± 1970	11,200 ± 1970	1.11 ± 0.263
	Tramiprosate	7	2.898 ± 0.603	865 ± 172	4100 ± 687	5020 ± 859	36.1 ± 4.15

Dosing schedule: Days 1–6: 265 mg ALZ-801 tablet once daily on day 1 and twice daily on days 2–6; day 7: 265 mg ALZ-801 tablet once daily

Data are expressed as mean ± SD

PK pharmacokinetic, C _max maximum concentration, T _max time to reach C _max, AUC ₁₂ area under the concentration–time curve from time zero to 12 h, AUC ₂₄ area under the concentration–time curve from time zero to 24 h, t _½ half-life, SD standard deviation