ADME Study of [14C]-APX001 in Healthy Male Subjects (QSC117978)
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]-APX001 in Healthy Male Subjects after Oral and Intravenous Dosing
IRAS ID
244159
Contact name
Eric Ople
Contact email
Sponsor organisation
Amplyx Pharmaceuticals
Eudract number
2018-000901-21
Duration of Study in the UK
0 years, 1 months, 0 days
Research summary
The Sponsor Amplyx Pharmaceuticals is developing a new test medicine APX001 for the treatment of invasive fungal infections.
The study will try to identify the amount of radioactivity found in the blood, urine and faeces following a single dose of radiolabelled APX001 ([14C]-APX001), either given by mouth or directly into the vein (intravenously). "Radiolabelled’ means that the test medicine has a radioactive component which helps us to track where the test medicine and it's breakdown products (it’s metabolites) are ie in the blood, urine and faeces. The study will also investigate the breakdown products of APX001 to find out their chemical structure.
The study will involve 10 healthy male volunteers. Five volunteers will each receive a single oral dose of 500 mg of radiolabelled APX001 as a solution to drink and 5 volunteers will each receive a single intravenous dose of 600 mg of radiolabelled APX001 as a slow injection into the vein (infusion over 3 hours). Blood, urine and faecal samples will then be collected at regular intervals from each volunteer who will be resident in the clinical unit for up to 17 days. It is planned that volunteers will be on-site for 15 days, unless they do not reach the required recovery limits.
REC name
HSC REC A
REC reference
18/NI/0118
Date of REC Opinion
13 Jul 2018
REC opinion
Further Information Favourable Opinion