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

May 5, 2023 updated by: Genor Biopharma Co., Ltd.

A Study of [14C]GB491 on Mass Balance and Biotransformation in Chinese 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Beijing GoBroad Boren Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 168 hours post dose
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.
Up to 360 hours post dose
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
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
Time Frame: Up to 168 hours post dose
Up to 168 hours post dose
Adverse events
Time Frame: Up to 360 hours post dose
The safety of healthy subjects after a single dose of [14C]GB491
Up to 360 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genor Biopharma Co., Ltd.

Investigators

  • Principal Investigator: Fang HOU, Master, Beijing GoBroad Boren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2022

Primary Completion (Actual)

November 14, 2022

Study Completion (Actual)

November 14, 2022

Study Registration Dates

First Submitted

April 23, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GB491-MB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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