Breast Cancer, Nonsmall Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DRUG[14C]GB491
A single 150mg dose of GB491 containing approximately 50 uCi of \[14C\]GB491.
Sponsors
Genor Biopharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* A healthy male volunteer between 18 and 50 years of age inclusive * A total body weight \>=50kg, and a BMI of 19.0-26.0 kg/m2 * A signed informed consent document
Exclusion criteria
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease * Subjects with HBsAg-positive, or HCV-Ab-positive, or TPPA-positive, or HIV infection * Subjects with a history of habitual constipation/diarrhea, irritable bowel syndrome, or inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total radioactivity in plasma PK | Up to 168 hours post dose | 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. |
| Total radioactivity in urine and fecal samples | Up to 360 hours post dose | Quantitative analysis of total radioactivity in urine or feces in healthy subjects after a single dose of \[14C\]GB491. |
| Metabolite G1T30 and other major matabolites (if applicable) | Up to 168 hours post dose | Identify the main metabolites in healthy subjects after oral administration of \[14C\]GB491 to determine the main biotransformation pathway |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative analysis of drug concentrations of GB491, metabolite G1T30 and other major metabolites (if applicable) in plasma | Up to 168 hours post dose | — |
| Adverse events | Up to 360 hours post dose | The safety of healthy subjects after a single dose of \[14C\]GB491 |
Countries
China
Outcome results
None listed