ADME study for [14C]-MD1003 in Healthy Male Subjects (QSC201639)
Research type
Research Study
Full title
An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-MD1003 in Healthy Male Subjects
IRAS ID
271587
Contact name
Somasekhara Menakuru
Contact email
Sponsor organisation
MedDay Phamaceuticals
Eudract number
2019-003122-24
Duration of Study in the UK
0 years, 1 months, 0 days
Research summary
The sponsor, MedDay Pharmaceuticals is developing a test medicine, MD1003, to treat progressive multiple sclerosis (MS). MS is an autoimmune neurological disorder, damaging the cells in the brain and spinal cord.
This leads to a variety of symptoms including muscle weakness and spasms, mobility problems and fatigue. Progressive MS is where symptoms get gradually worse, with infrequent periods of remission or breaks in symptoms. MD1003 is a high dose of biotin, which is a vitamin involved in energy production in the body. Researchers anticipate that MD1003 will help to reduce the symptoms of MS.
This study involves radiolabelling (labelling the test medicine with radioactive 14C) which is used to locate the test medicine within the body. The study aims to determine the rate and route of elimination of [14C]-MD1003, along with the extent of distribution of radioactivity into blood cells. Safety and tolerability of the test medicine will also be assessed.
Blood, urine and faecal samples will be collected from subjects, allowing identification and profiling of breakdown products (metabolites) from MD1003 to learn the structure and properties of these. The amount of [14C]-MD1003 found in each sample will also be assessed.
Up to 6 healthy male volunteers will be enrolled in this study. Each volunteer will receive a single oral dose of 100 mg of radiolabelled-MD1003 ([14C]-MD1003). Blood, urine and faecal samples will be taken at regular intervals for approximately 8 days, or a maximum of 10 days, whilst they are resident in the clinical unit.
REC name
HSC REC B
REC reference
19/NI/0195
Date of REC Opinion
12 Nov 2019
REC opinion
Favourable Opinion