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

Phase 1

Completed

• Conditions: Nonsmall Cell Lung Cancer; Breast Cancer
• Interventions: Drug: [14C]GB491

• Registration Number: NCT05860582
• Lead Sponsor: Genor Biopharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-14
• Primary Completion: 2022-11-14
• Study Completion: 2022-11-14
• Study First Submitted: 2023-04-23
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-05
• Last Update Submitted: 2023-05-05
• Study First Posted: 2023-05-16
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]GB491	[14C]GB491	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beijing GoBroad Boren Hospital; 🇨🇳 Beijing, Beijing, China