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

NCT05860582 | Completed Phase 1

• 1 other identifier: GB491-MB
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Nonsmall Cell Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (1)

[14C]GB491

EXPERIMENTAL

Drug: [14C]GB491

Interventions

[14C]GB491 DRUG

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

[14C]GB491

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genor Biopharma Co., Ltd.: lead

Study Sites (1)

Beijing GoBroad Boren Hospital

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fang HOU, Master

  Beijing GoBroad Boren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 16, 2023
• Study Start: September 14, 2022
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)