This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and Excretion) of 14C labeled SLV337 after a single dose of an oral suspension.
The Absorption, Disposition, Metabolism and Excretion of SLV337 will be investigated after a single dose of an oral suspension of 14C-SLV337.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
400 mg experimental
5 x 200 mg immediate release capsule
Site Reference ID/Investigator# 61345
Zuidlaren, Netherlands
AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 (Part 1 and Part 2)
Time frame: Part 1: 5 days Part 2: 8 days
AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 acyl-glucoronide (Part 2)
Time frame: Part 2: 8 days
Excretion balance of total 14C-radioactivity (Part 2)
Time frame: Part 2: 8 days
Total 14C-radioactivity (Part 2)
Time frame: Part 2: 8 days
Metabolic profiling and identification of 14C-labeled parent compound and metabolites of SLV337 in plasma, urine and feces (Part 2)
Time frame: Part 2: 8 days
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part 1 and Part 2)
Time frame: Part 1: 19 days Part 2: 15 days
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