Healthy VolunteersPhase 1NCT05103241
A Phase I Mass Balance Study of [14C]GP681 in Healthy Chinese Male Volunteers
A Phase 1 study testing [14C] GP681 in people with Healthy Volunteers, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of [14C]GP681 in healthy Chinese male volunteers, revealing the overall pharmacokinetic characteristics of GP681 in humans, and providing a reference for the rational… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- [14C] GP681
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2021to 22 Nov 2021
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 18 and 40years, inclusive;
- A history of regular bowel movements (average 1or 2 bowel movements per day)
- Body weight ≥50.0 kg and body mass index (BMI) between19-26 kg/m^2(inclusive);
- Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant;
- Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for at least half a year after the final dose of study drug
- Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.
Who cannot join
- History of allergic conditions or allergic diseases, or a history of allergic reactions attributed to GP681 or any of the ingredients of its formulation or similar drugs. Those who cannot follow a uniform diet for special dietary requirements.
- Subjects with swallowing difficulties, or have diseases such as hemorrhoids, perianal diseases with regular/bleeding in the stool, habitual constipation or diarrhea, irritable bowel syndrome and inflammatory bowel diseases, affecting drug absorption, distribution, metabolism, excretion or the efficacy and safety of the drug.
- History of gastrointestinal ulcer or bleeding; Or history of any clinically significant diseases or diseases which may affect the result of this study, such as gastrointestinal, circulatory, respiratory, endocrine, neurological, urinary, hematological, immunological, psychiatric and metabolic diseases;
- History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsade de pointes ventricular tachycardia, ventricular tachycardia, prolonged QT syndrome, or symptoms of prolonged QT syndrome and family history;
- Patients who have undergone surgery within 6 months before the screening period, or who have undergone major surgery within 28 days, or whose surgical incision is not completely healed; Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, prolonged general anesthesia, or an open biopsy or significant traumatic injury;
- Any positive test result of hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;
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- Received any drugs that inhibit or induce the CYP450 enzyme (i.e., inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors- SSRI-antidepressant, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) 30 days prior to screening period;
- Received any drugs (including Chinese herbal medicine, vitamins and supplements) within 14 days prior to dosing, or participation in another clinical trial within 3 months before dosing.
- Those who have lost blood or donated up to 400 mL within 3 months before dosing, or those who plan to donate blood within 1 month after the end of this study;
- Smoking more than 10 cigarettes per day;
- Average weekly intake of alcohol is more than 14 units alcohol (1 units ≈ 360 mL beer, or 45 mL spirits with 40% content, or 150 mL wine) within the 6 months prior to dosing, or a positive ethanol breath test at screening;
- Substance abuse or use of soft drugs (e.g., marijuana) in the 3 months prior to the screening period or use of hard drugs (e.g., cocaine, amphetamines, phenylcyclohexidine, etc.) in the 1 year prior to the screening period; Or screening for positive urine drug abuse (drug) tests;
- Habitual or excessive consumption (more than 8 cups, 1cup=250mL) of grapefruit juice, tea, coffee and/or caffeinated beverages;
- Workers engaged in conditions requiring long-term exposure to radioactivity; Or have significant radiation exposure (≥2 chest/abdomen CT, or ≥3 other types of X-ray examinations) within 1 year before this study or have participated in the radiopharmaceutical labeling test;
- Subjects with poor compliance, or not suitable for this study as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031
About this study
Official title: Single-center, Open-label, Non-randomized and Single-dose Clinical Trial to Explore the Mass Balance of Oral Suspension of 40 mg/100 μCi [14C]GP681 in Healthy Chinese Male Volunteers
This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of [14C]GP681 in healthy Chinese male volunteers, revealing the overall pharmacokinetic characteristics of GP681 in humans, and providing a reference for the rational administration.
- Conditions
- Healthy Volunteers
- Being tested
- [14C] GP681
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C] GP681Drug
40 mg suspension containing 100μCi of [14C]GP681
| Study group | Role | What they receive |
|---|---|---|
| [14C]GP681 | Experimental | Subject will receive single dose of orally [14C] GP681 . Receives: Drug: [14C] GP681 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The distribution of GP681 in the whole blood and plasma, and the radioactive pharmacokinetics following the single orally administered [14C]GP681 in healthy Chinese male volunteers.
The percentage of radioactive dose of [14C] radiolabelled GP681 recovered in blood and in total.
Measured: Up to 336 hours (approx) from the start of administration.
Quantitive analysis of whole radioactivity of excrement of orally administered [14C]GP681 in healthy Chinese male subjects to obtain the mass balance data and the main excretion pathway in human body.
The percentage of radioactive dose of [14C] radiolabelled GP681 recovered in urine, faeces and in total.
Measured: Up to 432 hours (approx) from the start of administration.
Quantitive analysis of the concentrations of GP681 and its major metabolites (such as GP1707D07) in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.
The concentrations of GP681 and its major metabolites in plasma.
Measured: Up to 336 hours (approx) from the start of administration.
Identification of the main metabolites and biotransformation pathway of GP681 following the single orally administered [14C]GP681 in healthy Chinese male volunteers
Proportion of different metabolites.
Measured: Up to 432 hours (approx) from the start of administration.
Evaluation of safety following the single orally administered [14C]GP681 in healthy Chinese male volunteers.
Adverse events assessed by NCI-CTCAE v5.0.
Measured: Up to 432 hours (approx) from the start of administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start26 Oct 2021
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label, radiolabeled, single-dose study of an oral solution of \[14C\]GP681(40mg/100μCi) in 6 healthy male volunteer.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103241
- Sponsor's protocol ID
- CRC-C2131
- Status last verified
- Nov 2021
- First submitted
- 21 Oct 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Open-label, Non-randomized and Single-dose Clinical Trial to Explore the Mass Balance of Oral Suspension of 40 mg/100 μCi [14C]GP681 in Healthy Chinese Male Volunteers
- ClinicalTrials.gov ID
- NCT05103241
- Acronym / sponsor ID
- CRC-C2131
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 2 Nov 2021 (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 study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of [14C]GP681 in healthy Chinese male volunteers, revealing the overall pharmacokinetic characteristics of GP681 in humans, and providing a reference for the rational administration.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, radiolabeled, single-dose study of an oral solution of [14C]GP681(40mg/100μCi) in 6 healthy male volunteer.
| Arm | Type | Receives |
|---|---|---|
| [14C]GP681 | Experimental | Drug: [14C] GP681Subject will receive single dose of orally [14C] GP681 . |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male subjects between the ages of 18 and 40years, inclusive;
- A history of regular bowel movements (average 1or 2 bowel movements per day)
- Body weight ≥50.0 kg and body mass index (BMI) between19-26 kg/m^2(inclusive);
- Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant;
- Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for at least half a year after the final dose of study drug
Key exclusion criteria (15 listed)
- History of allergic conditions or allergic diseases, or a history of allergic reactions attributed to GP681 or any of the ingredients of its formulation or similar drugs. Those who cannot follow a uniform diet for special dietary requirements.
- Subjects with swallowing difficulties, or have diseases such as hemorrhoids, perianal diseases with regular/bleeding in the stool, habitual constipation or diarrhea, irritable bowel syndrome and inflammatory bowel diseases, affecting drug absorption, distribution, metabolism, excretion or the efficacy and safety of the drug.
- History of gastrointestinal ulcer or bleeding; Or history of any clinically significant diseases or diseases which may affect the result of this study, such as gastrointestinal, circulatory, respiratory, endocrine, neurological, urinary, hematological, immunological, psychiatric and metabolic diseases;
- History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsade de pointes ventricular tachycardia, ventricular tachycardia, prolonged QT syndrome, or symptoms of prolonged QT syndrome and family history;
- Patients who have undergone surgery within 6 months before the screening period, or who have undergone major surgery within 28 days, or whose surgical incision is not completely healed; Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, prolonged general anesthesia, or an open biopsy or significant traumatic injury;
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] GP68140 mg suspension containing 100μCi of [14C]GP681 | Drug | [14C]GP681 |
Primary outcome
The distribution of GP681 in the whole blood and plasma, and the radioactive pharmacokinetics following the single orally administered [14C]GP681 in healthy Chinese male volunteers.
Time frame: Up to 336 hours (approx) from the start of administration.
The percentage of radioactive dose of [14C] radiolabelled GP681 recovered in blood and in total.
Quantitive analysis of whole radioactivity of excrement of orally administered [14C]GP681 in healthy Chinese male subjects to obtain the mass balance data and the main excretion pathway in human body.
Time frame: Up to 432 hours (approx) from the start of administration.
The percentage of radioactive dose of [14C] radiolabelled GP681 recovered in urine, faeces and in total.
Quantitive analysis of the concentrations of GP681 and its major metabolites (such as GP1707D07) in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.
Time frame: Up to 336 hours (approx) from the start of administration.
The concentrations of GP681 and its major metabolites in plasma.
Identification of the main metabolites and biotransformation pathway of GP681 following the single orally administered [14C]GP681 in healthy Chinese male volunteers
Time frame: Up to 432 hours (approx) from the start of administration.
Proportion of different metabolites.
Evaluation of safety following the single orally administered [14C]GP681 in healthy Chinese male volunteers.
Time frame: Up to 432 hours (approx) from the start of administration.
Adverse events assessed by NCI-CTCAE v5.0.
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 10 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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] GP681 in people with Healthy Volunteers, run by Jiangxi Qingfeng Pharmaceutical 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 6 inclusion and 15 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 10 Dec 2021. 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?
The distribution of GP681 in the whole blood and plasma, and the radioactive pharmacokinetics following the single orally administered [14C]GP681 in healthy Chinese male volunteers. (time frame: Up to 336 hours (approx) from the start of administration.). The study lists 5 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 10 Dec 2021.