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BRIEF-Resverlogix says proposed Phase 2A kidney dialysis study design to be separated in two parts
February 23, 2017 / 12:27 PM / 7 months ago

BRIEF-Resverlogix says proposed Phase 2A kidney dialysis study design to be separated in two parts

Feb 23 (Reuters) - Resverlogix Corp:

* Resverlogix - study to evaluate if treatment with apabetalone with standard of care decreases alkaline phosphatase in comparison to placebo and soc

* Resverlogix reports positive FDA type B meeting on design issues relating to a proposed phase 2A kidney dialysis trial

* Resverlogix Corp - in light of guidance received from FDA, phase 2A study design will be separated in two parts

* Resverlogix Corp - part a of study will involve a single-dose pharmacokinetic (PK) study in eight patients receiving hemodialysis

* Resverlogix Corp - PK results from part a will influence dose selection for part B study

* Resverlogix Corp - part B study will be a double-blind, randomized, placebo-controlled, sequential cross-over study with apabetalone

* Resverlogix Corp - intends to file an official investigative new drug (IND) application and proceed with planned phase 2A clinical trial in 2017 Source text for Eikon: Further company coverage:

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