Noretreat,

The duration of this Phase 1 trial was only one week. If you are not familiar with this trial, you should see here.The primary purpose was to prove that RVX-208/apabetalone is safe and has a similar pharmacokinetic/drug clearance profile in patients with impaired renal function relative to those with normal renal function. The primary outcome of this trial was no to show efficacy, just to "assess the pharmacokinetics (PK) of single oral administration of RVX000222 in subjects with severe renal impairment.....Method of assessment: PK blood and urine sampling."

They did, however, collect blood samples at a few time points during the week long trial in order to explore a secondary outcome via SOMAscan analysis (results still pending):

"The exploratory objective of the study is to evaluate acute changes in biomarker relevant to Bromodomain Extra Terminal (BET) inhibition. A proteomic analysis involving 1300 protein markers will be conducted. The analysis will be conducted using the SOMAscan assay and reagents offered by SomaLogic (http://www.somalogic.com/About-Us.aspx)."

Now that this is out of the way, they have the confidence that patients with renal impairment in their upcoming renal trials(s) will metabolize RVX-208/apabetalone similar to healthy patients.

BearDownAZ