This is a Phase 1, 2-period, open-label, single-dose, fixed-sequence study to assess the absolute bioavailability, absorption, metabolism, excretion, and mass balance of \[14C\]-NX-5948. Period 1 will analyze PD (pharmacodynamics) and exploratory biomarkers. Period 2 will analyze total radioactivity and metabolite profiling.
In Period 1 all subjects will receive a single dose of NX-5948 by IV and undergo pre and post dose labs to assess PK (pharmacokinetics) and PD parameters. In Period 2 all subjects will receive a single dose of NX-5948 by mouth. Pre and post dose blood, urine, and feces will be collected until NX-5948 is no longer identified in samples. Periods 1 and 2: Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
NX-5948 will be given once by IV and then given once by mouth.
Celerion
Lincoln, Nebraska, United States
Characterize Area Under the Curve (AUC0-inf), Half-life (T1/2) after IV dosing of NX-5948
Characterize the Area Under the Curve (AUC0-inf), Half-life (T1/2) of a single IV dose of NX-5948 in healthy adult male subjects.
Time frame: 9 weeks
Evaluation of metabolite after oral dosing with [14C]-NX-5948
Identify major metabolite and its AUC in plasma following a single oral dose of \[14C\]-NX-5948 in healthy adult male subjects.
Time frame: 9 weeks
Assessment of bioavailability with oral dosing of NX-5948
Determine the absolute bioavailability (ABA) of an oral formulation of \[NX-5948C\]- in healthy adult male subjects.
Time frame: 9 weeks
Assessment of total radioactivity after oral dosing with NX-5948
Determine the recovery of total radioactivity (TRA; mass balance) as a percentage of the administered dose after a single oral dose of \[14C\]-NX-5948 in healthy adult male subjects.
Time frame: 9 weeks
Assessment of whole blood to plasma ratio for TRA after oral dosing with NX-5948
Characterize whole blood to plasma ratio for TRA following a single oral dose of \[14C\]-NX-5948 in healthy adult male subjects (i.e., whole blood:plasma partitioning ratio).
Time frame: 9 weeks
Characterize the Clearance (CL) after IV dosing of NX-5948
Character the Clearance (CL) after IV dosing of NX-5948in healthy adults male subjects.
Time frame: 9 weeks
Characterize the Volume of distribution (Vz) after IV dosing of NX-5948
Character the Volume of distribution (Vz) after IV dosing of NX-5948in healthy adults male subjects.
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Time frame: 9 weeks