This single centre, open-label, non-randomised, single period, single-dose study in healthy male subjects was designed and conducted to assess the mass balance recovery, PK, metabolite profile and metabolite identification of SJP-0008.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Single oral dose of \[14C\]SJP-0008
Quotient Sciences
Ruddington, Nottingham, United Kingdom
Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]SJP-0008
Mass balance recovery of total radioactivity in all excreta by analysing the total radioactivity and metabolic profile in plasma, urine and faeces samples.
Time frame: Until the mass balance criteria for all participants have been met (estimated up to Day 10)
Maximum plasma concentration (Cmax) of SJP-0008 and SNJ-2026
Time frame: Up to Day 8
Area under the concentration-time curve from time zero to last measurable concentration (AUC0-last) of SJP-0008 and SNJ-2026
Time frame: Up to Day 8
Area under concentration-time curve from time zero to infinity (AUC0-inf) of SJP-0008 and SNJ-2026
Time frame: Up to Day 8
Area under the concentration-time curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) of SJP-0008 and SNJ-2026
Time frame: Up to Day 8
Time to maximum plasma concentration (Tmax) of SJP-0008 and SNJ-2026
Time frame: Up to Day 8
Half-life (T1/2) of SJP-0008 and SNJ-2026
Time frame: Up to Day 8
First order rate constant associated with the terminal (log-linear) portion of the curve (Lambda-z) of SJP-0008 and SNJ-2026
Time frame: Up to Day 8
Percentage of participants with adverse events (AEs)
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Time frame: Until the mass balance criteria for all participants have been met (estimated up to Day 10)