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

Sponsor
Genor Biopharma Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05860582
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
2
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study of [14C]GB491 on Mass Balance and Biotransformation in Chinese Male Healthy Subjects
Actual Study Start Date :
Sep 14, 2022
Actual Primary Completion Date :
Nov 14, 2022
Actual Study Completion Date :
Nov 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: [14C]GB491

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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

  1. Quantitative analysis of drug concentrations of GB491, metabolite G1T30 and other major metabolites (if applicable) in plasma [Up to 168 hours post dose]

  2. Adverse events [Up to 360 hours post dose]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing GoBroad Boren Hospital Beijing Beijing China 100070

Sponsors and Collaborators

  • Genor Biopharma Co., Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Genor Biopharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05860582
Other Study ID Numbers:
  • GB491-MB
First Posted:
May 16, 2023
Last Update Posted:
May 16, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of May 16, 2023