This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of 14C-XEN1101 in healthy adult male subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101
Quotient Sciences
Ruddington, Nottingham, United Kingdom
Total radioactivity excreted in urine and faeces following oral administration of XEN1101
Cumulative amount of total radioactivity excreted in urine and feces combined (CumAe(total)) and expressed as a % of the radioactive dose administered (Cum%Ae(total)) following oral administration of 14C-XEN1101
Time frame: From Screening up to Day 57 post-dose
14C Metabolite profiling in of plasma, urine and feces
Chemical structure of each metabolite classified as \>10% (by AUC) of total radioactivity in plasma and \>10% dose excreted in urine and faeces following oral administration of XEN1101
Time frame: From Screening up to Day 57 post-dose
Pharmacokinetic (PK) data for 14C-XEN1101; Tmax
Time of maximum observed concentration for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101
Time frame: From Screening up to Day 57 post-dose
PK data for 14C-XEN1101; Cmax
Maximum observed concentration for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101
Time frame: From Screening up to Day 57 post-dose
PK data for 14C-XEN1101; T1/2
Terminal elimination half-life for XEN1101 and metabolites in plasma and for total radioactivity in plasma and whole blood following oral administration of 14C-XEN1101
Time frame: From Screening up to Day 57 post-dose
Mass balance data for 14C-XEN1101 in urine
CumAe(urine)expressed as a percentage of the radioactive dose administered (Cum%Ae(urine))
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From Screening up to Day 57 post-dose
Mass balance data for 14C-XEN1101 in feces
CumAe(feces) expressed as a percentage of the radioactive dose administered Cum%Ae(feces)
Time frame: From Screening up to Day 57 post-dose
Plasma whole blood concentration ratios for total radioactivity
Evaluation of whole blood:plasma concentration ratios for total radioactivity for corresponding time points
Time frame: From Screening up to Day 57 post-dose
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations
Time frame: From Screening up to Day 57 post-dose