Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of \[14C\] ASN002 Following a Single Oral Dose in Healthy Male Subjects
This will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male subjects. Subjects will be admitted into the Clinical Research Unit (CRU) on Day 1 and be confined to the CRU until at least Day 7. On Day 1, subjects will receive a single oral dose of \[14C\] ASN002 at 60 mg containing approximately 300 μCi \[14C\] ASN002. Subjects will be discharged on Day 7 if the following discharge criteria are met: plasma radioactivity levels below the limit of quantitation for 2 consecutive collections, and ≥90% mass balance recovery, or ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 3 consecutive 24 hour periods. If discharge criteria are not met by Day 7, subjects will remain in the CRU up to a maximum of Day 10.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
8
\[14C\] ASN002
Covance Clinical Research Unit
Madison, Wisconsin, United States
Cmax - maximum observed plasma concentration (plasma and whole blood)
Time frame: at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.
tmax - time at which Cmax occurs (plasma and whole blood)
Time frame: at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.
AUC0 t - area under the plasma concentration time curve from time zero to the last measurable concentration (plasma and whole blood)
Time frame: at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.
AUC0-∞ - area under the plasma concentration-time curve from time zero to infinity (plasma and whole blood)
Time frame: at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.
t½ - apparent terminal elimination half-life (plasma and whole blood)
Time frame: at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.
CL/F - apparent total clearance (plasma and whole blood)
Time frame: at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.
VZ/F - apparent volume of distribution (plasma and whole blood)
Time frame: at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.
Total radioactivity in urine and feces
%Ae (urine), %Ae (feces) and %Ae (total): amount excreted and cumulative amount excreted in urine and feces
Time frame: at pre-dose and up to 144 hours post-dose. If collection is extended up to Day 10: at up to 216 hours post-dose.
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Metabolic Profiling/identification and determination of relative abundance of ASN002 and the metabolites of ASN002 in plasma, urine, and feces
Time frame: Up to 10 days
Safety and tolerability as measured by incidence and severity of adverse events (AEs)
Time frame: Up to 10 days