Tada asked a question regarding this part of the Part A protocol:
"Are unwilling to abstain from alcoholic beverages, caffeine or xanthine-containing products (e.g., tea, coffee, chocolate, cola), and use of nicotine products from 24 hours prior to Clinical Research Unit (CRU) admission to 48 hours post RVX000222 dose administration."
My guess is that it has something to do with the fact that Part A is a pure pharmacokinetic (PK) evaluation of a single dose of apabetalone/RVX-208. I am guessing that it is pretty standard practice to have subjects abstain from alcohol, caffeine and nicotine in order to obtain the most reliable, informative and reproducible PK data. They only have 8 End Stage Renal Disease (ESRD) subjects in part A, measured on both dialysis and non-dialysis days. By abstaining from these items for the 24 hours prior to dosing to 48 hours post-dosing, this will minimize the inter-patient variability and variability between dialysis and non-dialysis days. The best experiment is a well controlled experiment! PK evaluation involves absorption, metabolism and clearance of the test compound (apabetalone), so I am assuming that there is some concern that one of these parameters may be affected by caffeine, alcohol or nicotine. This is likely standard practice for PK analyses. Also, the presence of alcohol, caffeine or nicotine as well as their by-products, may not only indirectly affect the PK analysis but may also interfere in some way in the readout from the analytical instrumentation.
BearDownAZÂ
