This is a Phase 1, open label study in healthy male participants to study the Absorption, Distribution, Metabolism, and Excretion of \[14C\]-MRM-3379 drug following a single oral dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
Oral capsule administered on Day 1 only.
Fortrea Clinical Research Unit Inc
Madison, Wisconsin, United States
RECRUITINGTotal radioactivity recovery of MRM-3379 in urine and feces
Evaluate the cumulative and total radioactivity in urine and feces following administration of a single oral dose of radiolabeled MRM-3379.
Time frame: Up to 11 days post dose
Maximum observed concentration (Cmax) of MRM-3379 and 2 metabolites in plasma
Time frame: Up to 11 days post dose
Time to maximum observed concentration (tmax) of MRM-3379 and 2 metabolites in plasma
Time frame: up to 11 days post dose
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-tlast) of MRM-3379 and 2 metabolites in plasma
Time frame: up to 11 days post dose
Maximum observed concentration (Cmax) of total radioactivity in plasma and whole blood
Time frame: up to 11 days post dose
Time to maximum observed concentration (tmax) of total radioactivity in plasma and whole blood
Time frame: up to 11 days post dose
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-tlast) of total radioactivity in plasma and whole blood
Time frame: Up to 11 days post dose
Amount of MRM-3379 and 2 metabolites excreted in the urine (Ae) over sampling period
Time frame: Up to 11 days post dose
Fraction of MRM-3379 and 2 metabolites excreted in the urine (Fe) as Ae/dose
Time frame: Up to 11 days post dose
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Renal clearance of MRM-3379 as Ae/AUC
Time frame: Up to 11 days post dose
Assessment of metabolites in plasma and excreta by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Evaluate the quantitative metabolic profile of MRM-3379 in plasma, urine, and feces via radiochromatographic profiles and identify associated metabolites following administration of a single oral dose of radiolabeled MRM-3379.
Time frame: Up to 11 days post dose
Number of subjects with treatment-related adverse events
Time frame: Up to 11 days post dose