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NCT Number: NCT05860582

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nonsmall Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Beijing GoBroad Boren Hospital

Beijing, Beijing Municipality, 100070, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[14C]GB491

Drug

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

Primary outcomes

  1. Total radioactivity in plasma PK

    Time frame: 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.

  2. Total radioactivity in urine and fecal samples

    Time frame: 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.

  3. Metabolite G1T30 and other major matabolites (if applicable)

    Time frame: 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 outcomes

  1. Quantitative analysis of drug concentrations of GB491, metabolite G1T30 and other major metabolites (if applicable) in plasma

    Time frame: Up to 168 hours post dose

  2. Adverse events

    Time frame: Up to 360 hours post dose

    The safety of healthy subjects after a single dose of [14C]GB491

Sponsors and collaborators

Lead sponsor

Genor Biopharma Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 16, 2023
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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