The main purpose of this study is to determine the mass balance recovery and the metabolite profile of a single dose of carbon-14 (\[14C\]) GRT6019
This is an open-label, non-randomized, single-dose study in healthy male participants. It is planned to enroll a total of ten participants to ensure data in a minimum of six participants. The estimated time for duration of study will be up to 11 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
10
Single administration in a single dosing period.
Quotient Sciences
Nottingham, United Kingdom
Cumulative amount of total radioactivity excreted (CumAe)
To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of \[14C\]GRT6019
Time frame: Day -1 (Admission), Day 1 up to Days 47-48.
Cumulative amount of total radioactivity excreted expressed as a percentage of the radioactive dose administered (Cum%Ae)
To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of \[14C\]GRT6019
Time frame: Day -1 (Admission), Day 1 up to Days 47-48.
Metabolite profling and structural identification
To perform metabolite profiling, structural identification, and quantification analysis from plasma, urine and faecal samples
Time frame: Day -1 (Admission), Day 1 up to Days 47-48.
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