Breast CancerPhase 1NCT05860582
A Study of [14C]GB491 in Male Healthy Subjects
A Phase 1 study testing [14C]GB491 in people with Breast Cancer and Nonsmall Cell Lung Cancer, run by Genor Biopharma Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Nonsmall Cell Lung Cancer
- What is being tested?
- [14C]GB491
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2022to 14 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing GoBroad Boren Hospital
Beijing, Beijing Municipality, 100070
About this study
Official title: 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.
- Conditions
- Breast Cancer, Nonsmall Cell Lung Cancer
- Being tested
- [14C]GB491
- Medical subject headings
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]GB491Drug
A single 150mg dose of GB491 containing approximately 50 uCi of [14C]GB491.
| Study group | Role | What they receive |
|---|---|---|
| [14C]GB491 | Experimental | Not described Receives: Drug: [14C]GB491 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to 168 hours post dose
Adverse events
The safety of healthy subjects after a single dose of [14C]GB491
Measured: Up to 360 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start14 Sep 2022
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genor Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fang HOU, Master, Principal investigator, Beijing GoBroad Boren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860582
- Sponsor's protocol ID
- GB491-MB
- Status last verified
- May 2023
- First submitted
- 23 Apr 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of [14C]GB491 on Mass Balance and Biotransformation in Chinese Male Healthy Subjects
- ClinicalTrials.gov ID
- NCT05860582
- Acronym / sponsor ID
- GB491-MB
- Conditions
- Breast Cancer, Nonsmall Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]GB491 | Experimental | Drug: [14C]GB491 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]GB491A single 150mg dose of GB491 containing approximately 50 uCi of [14C]GB491. | Drug | [14C]GB491 |
Primary outcome
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.
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.
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
2 secondary outcomes
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
Adverse events
Time frame: Up to 360 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang HOU, Master principal investigator
Beijing GoBroad Boren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]GB491 in people with Breast Cancer and Nonsmall Cell Lung Cancer, run by Genor Biopharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total radioactivity in plasma PK (time frame: Up to 168 hours post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.