A Study of [14C]GB491 in Male Healthy Subjects

Study Overview
=================
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.

Official Title
-----------------
A Study of [14C]GB491 on Mass Balance and Biotransformation in Chinese Male Healthy Subjects

Conditions
-----------------
Breast Cancer, Nonsmall Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: [14C]GB491


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]GB491<br> | Drug: [14C]GB491<br>* A single 150mg dose of GB491 containing approximately 50 uCi of [14C]GB491.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | Up to 168 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The safety of healthy subjects after a single dose of [14C]GB491 | Up to 360 hours post dose |