This is a single-centre, open-label, non-randomised, single oral dose study in healthy male subjects to assess the mass balance recovery of carbon-14 (14C)-BTD-001.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
Carbon-14 labeled BTD-001
Quotient Clinical
Ruddington, United Kingdom
Mass balance recovery after a single dose of carbon-14 (14C)-BTD-001
The percentage of radioactive dose of \[14C\] radiolabelled BTD-001 recovered in urine, faeces, and plasma
Time frame: Maximum 12 days
Metabolite Profiling
To provide plasma, urine and faecal samples for metabolite profiling and structural identification
Time frame: Maximum 12 days
Determination of routes and rates of elimination of [14C]-BTD-001
\[14C\]-BTD-001 metabolite profiling and structural identification in plasma, urine and faeces
Time frame: Maximum 12 days
Determination of the chemical structure of the "major" metabolites of [14C]-BTD-001
Identification of the chemical structure of each metabolite accounting for more than 10% (by AUC) of circulating total radioactivity
Time frame: Maximum 12 days
Evaluation of whole blood:plasma concentration ratios for total radioactivity
To evaluate the extent of distribution of total radioactivity into blood cells
Time frame: Maximum 12 days
physical examination
Safety and tolerability of BTD-001 by assessing physical examination
Time frame: Maximum 12 days
safety laboratory tests
Safety and tolerability of BTD-001 by assessingsafety laboratory tests and AEs
Time frame: Maximum 12 days
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Vital signs
Safety and tolerability of BTD-001 by assessing vital signs
Time frame: Maximum 12 days
ECGs
Safety and tolerability of BTD-001 by assessing ECGs
Time frame: Maximum 12 days
AEs
Safety and tolerability of BTD-001 by assessing physical examination AEs
Time frame: Maximum 12 days