This is an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of GB491 in 4-8 healthy male subjects receiving a single oral 150mg dose of GB491 containing approximately 50 uCi of \[14C\]GB491. This study will help understand how the drug appears in the blood, urine, and feces after it is administered. In addition, this study will also evaluate the safety of a single dose of \[14C\]GB491 when given to healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
A single 150mg dose of GB491 containing approximately 50 uCi of \[14C\]GB491.
Beijing GoBroad Boren Hospital
Beijing, Beijing Municipality, China
Total radioactivity in plasma PK
To investigate the distribution ratio of total radioactivity in whole blood to plasma and pharmacokinetic characteristics of total radioactivity in plasma in healthy subjects after a single dose of \[14C\]GB491.
Time frame: Up to 168 hours post dose
Total radioactivity in urine and fecal samples
Quantitative analysis of total radioactivity in urine or feces in healthy subjects after a single dose of \[14C\]GB491.
Time frame: Up to 360 hours post dose
Metabolite G1T30 and other major matabolites (if applicable)
Identify the main metabolites in healthy subjects after oral administration of \[14C\]GB491 to determine the main biotransformation pathway
Time frame: Up to 168 hours post dose
Quantitative analysis of drug concentrations of GB491, metabolite G1T30 and other major metabolites (if applicable) in plasma
Time frame: Up to 168 hours post dose
Adverse events
The safety of healthy subjects after a single dose of \[14C\]GB491
Time frame: Up to 360 hours post dose
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