Phase I MAD, Fed-Fasted, CSF Study of UE2343 in Healthy Subjects

Phase 1 Completed 40 enrolled Actinogen Medical Linear Clinical Research · collab Novotech (Australia) Pty Limited · collab

RandomizedFactorialDouble-blindTreatment

Summary

The purpose of this study is to determine whether the drug UE2343, a potential treatment for Alzheimer's Disease (AD), is effective by assessing safety, tolerability, pharmacokinetics and pharmacodynamics in a Multiple Ascending Dose Study. Protocol amendments to the study will examine any food effect and determine if the drug penetrates the Blood-Brain Barrier.

Timeline

Start: 2015-02
Primary completion: 2015-08
Completion: 2015-09

Publications

Results Webster SP, McBride A, Binnie M, Sooy K, Seckl JR, Andrew R, Pallin TD, Hunt HJ, Perrior TR, Ruffles VS, Ketelbey JW, Boyd A, Walker BR. Selection and early clinical evaluation of the brain-penetrant 11beta-hydroxysteroid dehydrogenase type 1 (11beta-HSD1) inhibitor UE2343 (Xanamem). Br J Pharmacol. 2017 Mar;174(5):396-408. doi: 10.1111/bph.13699. Epub 2017 Jan 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EMESTEDASTAT	Small molecule	10 mg	Oral
Subject	EMESTEDASTAT	Small molecule	20 mg	Oral
Subject	EMESTEDASTAT	Small molecule	35 mg	Oral

Indications

No indication recorded.