Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Formulations and Doses of PWT-143

Summary

This single center first in human (FIH) study will comprise 2 parts; Part 1 will consist of 3 sequential dose groups (Groups A, B and C) and Part 2 will consist of 1 dose group (Group A). There will be an option to include 2 additional dose groups in Part 1 (Groups D and E) to assess alternative dose levels or formulations, if required. In each study part, each subject will receive a single dose of investigational medicinal product PWT-143 in each of 2 study periods (total of 2 single doses).

Timeline

Start

2015-06-29

Primary completion

2017-02-24

Completion

2017-02-24

Publications

• Moreno O, Butler T, Zann V, Willson A, Leung P, Connor A. Safety, Pharmacokinetics, and Pharmacodynamics of ME-401, an Oral, Potent, and Selective Inhibitor of Phosphatidylinositol 3-Kinase P110delta, Following Single Ascending Dose Administration to Healthy Volunteers. Clin Ther. 2018 Nov;40(11):1855-1867. doi: 10.1016/j.clinthera.2018.09.006. Epub 2018 Oct 26.

Drugs

Indications