The objective of this study is to assess the mass balance and routes of excretion of total radioactivity after a single oral dose of 1600 mg \[14C\]-NV-5138.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Single dose, given as oral solution, 1600 mg
Quotient Sciences
Ruddington, Nottingham, United Kingdom
Cumulative total radioactivity in urine and faeces
The percentage of the radioactive dose recovered in urine, faeces and in total
Time frame: urine and fecal samples up to 168 hours post dose
AUCinf for NV-5138, metabolite M8 and total radioactivity in plasma whole blood
Area under the concentration-time curve from time zero (pre-dose) to infinity
Time frame: up to 168 hours post-dose
AUClast for NV-5138, metabolite M8 and total radioactivity in plasma whole blood
Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration
Time frame: up to 168 hours post-dose
Cmax for NV-5138, metabolite M8 and total radioactivity in plasma whole blood
Maximum observed concentration
Time frame: up to 168 hours post-dose
Tmax for NV-5138, metabolite M8 and total radioactivity in plasma whole blood
Time of maximum observed concentration
Time frame: up to 168 hours post-dose
Tlast for NV-5138, metabolite M8 and total radioactivity in plasma whole blood
Time of the last measurable concentration
Time frame: up to 168 hours post-dose
t1/2 for NV-5138 and total radioactivity in plasma and whole blood
Terminal elimination half-life
Time frame: up to 168 hours post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CL/F for NV-5138 in plasma
Total oral clearance
Time frame: up to 168 hours post-dose
Vz/F for NV-5138 in plasma
Apparent volume of distribution
Time frame: up to 168 hours post-dose
MPR Cmax in plasma
metabolite to parent ration based on Cmax
Time frame: up to 168 hours post-dose
MPR AUCinf in plasma
metabolite to parent ration based on AUCinf
Time frame: up to 168 hours post-dose
Whole blood to plasma partitioning for total radioactivity
The AUCinf ratio of whole blood to plasma
Time frame: up to 168 hours post-dose
CLR for NV-5138
Renal clearance
Time frame: up to 168 hours post-dose
Ae for total radioactivity in urine and feces
amount of total radioactivity excreted over each sampling period
Time frame: up to 168 hours post-dose
%Dose for total radioactivity in urine and feces
amount of total radioactivity eliminated in faeces expressed as a percentage of the radioactive dose administered over each sampling period
Time frame: up to 168 hours post-dose
Characterization of metabolites in plasma, urine and fecal homogenates
Identification and quantification NV-5138 related metabolites
Time frame: up to 168 hours post-dose