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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05860582
• Other study ID #: GB491-MB
• Status: Completed
• Phase: Phase 1
• Start date: September 14, 2022
• Est. completion date: November 14, 2022

Study information

• Verified date: May 2023
• Source: Genor Biopharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 14, 2022
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Non-Small-Cell Lung
• Nonsmall Cell Lung Cancer

Intervention

Drug:
• [14C]GB491
A single 150mg dose of GB491 containing approximately 50 uCi of [14C]GB491.

Locations

Country	Name	City	State
China	Beijing GoBroad Boren Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Genor Biopharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Quantitative analysis of drug concentrations of GB491, metabolite G1T30 and other major metabolites (if applicable) in plasma		Up to 168 hours post dose
Secondary	Adverse events	The safety of healthy subjects after a single dose of [14C]GB491	Up to 360 hours post dose