IF you want to follow further:
(P1a): vikingtherapeutics.com
<Dose-dependent mean reductions in total and free T4, total T3 and TSH were observed beginning at day 8, but without symptoms or signs of thyroid dysfunction.>
and
(Pre-clinical, MB07344, MB07811)):
ncbi.nlm.nih.gov and
ncbi.nlm.nih.gov
dmd.aspetjournals.org
Figure 2, two unknown metabolites: <Metabolism of MB07811 in Liver Microsomes. The rate of metabolism of MB07811 in liver microsomes, as measured by the apparent rate of disappearance of the prodrug peak over time, was highest in the male SD rat liver S9 and microsomes and lowest in the male human ( Fig. 2). The general pattern of the profile of the major metabolites was similar between the species: MB07344 and an unknown metabolite, eluting approximately 4 min later, were observed in all species, and both increased over time. In addition, an unresolved peak of radioactivity at the solvent front increased over time in all species. The glutathione adduct by-product MB06588 was observed in most of the UV traces of samples from all species. One minor metabolite peak eluting approximately 2 min before the MB07344 peak was detected in human and monkey samples and, to a lesser extent, in dog samples. This peak was not observed in either male or female rat samples. MB07811 was poorly converted to MB07344 in female SD rat liver S9 and microsomes.>
To be clear, I am not saying that there is tox problem with VK2809,.... but who is to say that there is not, that it is clear?
Also, "UNKNOWN" metabolite is not terminology that FDA looks favorable at! |
