ADME and IVMT study of ME-401 in healthy subjects (QSC201587)
Research type
Research Study
Full title
An Open Label, Two-part Study Designed to Assess the Absolute Bioavailability of ME-401 and the Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structures for [14C]-ME-401 in Healthy Male Subjects
IRAS ID
264687
Contact name
Igor Gorbatchevsky
Contact email
Sponsor organisation
MEI Pharma, Inc.
Eudract number
2019-001603-20
Duration of Study in the UK
0 years, 1 months, 9 days
Research summary
Summary of Research
MEI Pharma (the sponsor) is developing a new test medicine to treat certain cancers that begin in blood forming-tissue, such as non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukaemia (CLL).
The study will use radiolabelled ME-401 to identify how the medicine is taken up, absorbed, processed and\nremoved by the body. Radiolabelled means that the test medicine has a radioactive component which helps us to track where the drug is in the body. The type of radioactivity used, carbon 14, is naturally occurring radioactivity that will allow us to trace the study drug in the blood and assess how much is being taken up into/broken down in the body.
The study will consist of 2 parts involving up to 6 healthy male volunteers. In Part 1, up to 6 volunteers will receive a dose of ME-401 capsules by mouth followed by a 15 minute infusion of [14C]-ME-401 solution into a vein. In Part 2, the same group of 6 volunteers will receive a single dose of [14C]-ME-401 solution by mouth.
Summary of Results
Given that this is a phase 1 study evaluating drug-drug interaction in healthy volunteers, no lay summary of results has been provided for reasons of commercial confidentiality
REC name
HSC REC A
REC reference
19/NI/0135
Date of REC Opinion
26 Jul 2019
REC opinion
Favourable Opinion