Translational Medicine Communications

Table 2 Aceneuramic acid pharmacokinetic parameters in Trial-2

From: Phase I clinical trial results of aceneuramic acid for GNE myopathy in Japan

	2,000 mg × 1			2,000 mg × 3			2,000 mg × 3 × 7 days
Subject No.	1	2	3	4	5	7	1		3		4
							1st day	7th day	1st day	7th day	1st day	7th day
C_max (μg/mL)	0.624	0.319	0.106	0.233	0.335	0.095	0.172	0.285	0.093	0.146	0.169	0.234
T_max (h)	1	2	4	6	4	2	6	0	4	6	8	0
AUC, (μg·h/ml)	2.074	2.328	1.271	1.343	1.991	0.346	1.009	1.731	0.544	1.029	0.549	1.276
MRT (h)	5.288	5.122	9.095	4.609	4.075	3.288	4.799	4.122	4.644	4.129	5.759	3.842
λ_z(/h)	0.098	0.303	0.168	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.
T_1/2 (hrs)	7.089	2.291	4.138	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.
CL (mL/h)	819	846	1530	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.
Vd (ml)	8376	2795	9136	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.
AUC _0-∞ (μg·h/mL)	2.279	2.367	1.318	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.	N.A.

The baseline aceneuramic acid concentrations for each subject were subtracted from the corresponding concentrations for that point. For time points in which there is no corresponding baseline concentration, mean baseline concentration from that subject was subtracted to determine the net increase in aceneuramic concentration
Cmax, Tmax, AUCt, MRT are calculated based on the data before 2nd administration (8 h after 1st administration) in case of three times a day administration

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ISSN: 2396-832X

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