Healthy Male SubjectsPhase 1NCT04655872
Mass Balance of Oral [14C]TPN171H in Healthy Male Subjects
A Phase 1 study testing [14C]TPN171H in people with Healthy Male Subjects, run by Vigonvita Life Sciences at 1 site in China.
Trial summary
This study is objective to evaluate the in vivo absorption, excretion and biotransformation pathways of [14C]-TPN171H in Chinese male healthy volunteers, and to reveal the overall pharmacokinetic characteristics of TPN171H in human body, so as to provide basis for rational use of the drug. 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 Male Subjects
- What is being tested?
- [14C]TPN171H
- 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 Nov 2020to 27 Jan 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 19 and 55 years,with normal bowel movements (1~2 times a day);
- Body Mass Index of 19 to 26 kg/m2; Body weight no less than 50 kg;
- Physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry, thyroid function, stool routine and occult blood, etc.), 12 lead ECG, B-ultrasound, chest X-ray and fundus examination results were normal or abnormal without clinical significance;
- The male subjects with fertility had no child rearing plan or sperm donation plan with their sexual partners during the trial and within one year after taking the drug, and could take reliable contraceptive measures;
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and can complete the whole trial process according to the test requirements.
Who cannot join
- People with allergies or allergic diseases, or known allergies to test preparations, any of their ingredients, and related preparations;
- There are clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in B-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials Those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension;
- Blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration;
- Any drug that inhibits or induces liver drug-metabolizing enzymes (inducers-barbiturates, carbamazepine, phenytoin, rifampicin, dexamethasone, rifabutin, rifapentine) has been used within 30 days before administration ; Inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, verapamil, imidazole antifungals, sedatives and hypnotics, fluoroquinolones, antihistamines, etc.);
- Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before administration; or those who have participated in other drug clinical trials and received trial drugs within 3 months before administration;
- Those who have a history of drug dependence (including a history of drug use) within 2 years before administration; or urine drug abuse screening (morphine, tetrahydrocannabinol acid, methamphetamine, dimethylene oxyamphetamine) , Ketamine and cocaine) positive;
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- Those who smoke more than 10 cigarettes per day and do not agree to avoid using any tobacco products during the trial period;
- Positive results of alcohol breath test, or current/previous alcoholics (drinking more than 21 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL wine);
- People who have consumed excessive amounts of grapefruit juice, tea, coffee and/or caffeinated beverages for a long time (more than 8 cups a day, 1 cup equal to 250 mL);
- Those who are positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
- Blood loss or blood donation of 400 mL or more within 3 months before administration;
- Those who have been vaccinated within 6 months before administration;
- A history of fainting needles or fainting blood;
- Hemorrhoids or perianal diseases with regular/current stools; habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease;
- Workers who need to be exposed to radioactive conditions for a long time; or have significant radioactive exposure more than 2 chest/abdominal CT, or more than 3 other types of X-ray examinations) within 1 year before administration or participated in radiopharmaceutical labeling Experimenter
- The investigator believes that there are other factors that are not suitable for participating in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of the Mass Balance of a Single Oral Administration of [14C]TPN171H in Healthy Male Subjects
This study is objective to evaluate the in vivo absorption, excretion and biotransformation pathways of [14C]-TPN171H in Chinese male healthy volunteers, and to reveal the overall pharmacokinetic characteristics of TPN171H in human body, so as to provide basis for rational use of the drug.
Read the detailed description
This will be an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of TPN171H in approximately 6 healthy male subjects receiving a single oral 10 mg dose of TPN171H containing approximately 100 microcuries of [14C]-TPN171H. Subjects will be checked in to the research unit from approximately 24 hours prior to dosing and remain in house until greater than 80% of the administered radioactivity is collected from bodily excreta or until less than 1% of the administered radioactivity is recovered from excreta in two consecutive time intervals, and blood sample radioactivity concentration at two consecutive time points less than 3 times the plasma background value. This study will investigate the main biotransformation and elimination pathways of TPN171H in the human body and will seek to identify compound's major metabolites.
- Conditions
- Healthy Male Subjects
- Being tested
- [14C]TPN171H
- Keywords
- Mass balance, TPN171H, Simmerafil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]TPN171HDrug
A single 10 mg oral dose of [14C]TPN171H containing approximately 100 microcurie of [14C]-TPN171H.
| Study group | Role | What they receive |
|---|---|---|
| [14C]TPN171H | Experimental | Not described Receives: Drug: [14C]TPN171H |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - maximum observed plasma concentration
Measured: From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H
Tmax - time at which Cmax occurs
Measured: From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H
AUC0~t - area under the plasma concentration time curve from time zero to the last measurable concentration
Measured: From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H
AUC0-∞ - area under the plasma concentration-time curve from time zero to infinity
Measured: From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H
Total radioactivity in urine and faeces
Measured: From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start26 Nov 2020
- Primary completion27 Jan 2021
- Study completion27 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
- More trials run by Vigonvita Life SciencesThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vigonvita Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Institute of Materia Medica, Chinese Academy of Sciences
- Responsible party
- Sponsor
- Investigators
- Gangyi Liu, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655872
- Sponsor's protocol ID
- TPN171H-07
- Status last verified
- Nov 2020
- First submitted
- 23 Nov 2020
- Last updated
- 25 Feb 2021
- 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 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Mass Balance of a Single Oral Administration of [14C]TPN171H in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04655872
- Acronym / sponsor ID
- TPN171H-07
- Conditions
- Healthy Male Subjects
- Keywords
- Mass balance, TPN171H, Simmerafil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Vigonvita Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Institute of Materia Medica, Chinese Academy of Sciences
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 7 Dec 2020 (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 objective to evaluate the in vivo absorption, excretion and biotransformation pathways of [14C]-TPN171H in Chinese male healthy volunteers, and to reveal the overall pharmacokinetic characteristics of TPN171H in human body, so as to provide basis for rational use of the drug.
Detailed description
This will be an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of TPN171H in approximately 6 healthy male subjects receiving a single oral 10 mg dose of TPN171H containing approximately 100 microcuries of [14C]-TPN171H. Subjects will be checked in to the research unit from approximately 24 hours prior to dosing and remain in house until greater than 80% of the administered radioactivity is collected from bodily excreta or until less than 1% of the administered radioactivity is recovered from excreta in two consecutive time intervals, and blood sample radioactivity concentration at two consecutive time points less than 3 times the plasma background value. This study will investigate the main biotransformation and elimination pathways of TPN171H in the human body and will seek to identify compound's major metabolites.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]TPN171H | Experimental | Drug: [14C]TPN171H |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects between the ages of 19 and 55 years,with normal bowel movements (1~2 times a day);
- Body Mass Index of 19 to 26 kg/m2; Body weight no less than 50 kg;
- Physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry, thyroid function, stool routine and occult blood, etc.), 12 lead ECG, B-ultrasound, chest X-ray and fundus examination results were normal or abnormal without clinical significance;
- The male subjects with fertility had no child rearing plan or sperm donation plan with their sexual partners during the trial and within one year after taking the drug, and could take reliable contraceptive measures;
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and can complete the whole trial process according to the test requirements.
Key exclusion criteria (16 listed)
- People with allergies or allergic diseases, or known allergies to test preparations, any of their ingredients, and related preparations;
- There are clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in B-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials Those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension;
- Blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration;
- Any drug that inhibits or induces liver drug-metabolizing enzymes (inducers-barbiturates, carbamazepine, phenytoin, rifampicin, dexamethasone, rifabutin, rifapentine) has been used within 30 days before administration ; Inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, verapamil, imidazole antifungals, sedatives and hypnotics, fluoroquinolones, antihistamines, etc.);
- Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before administration; or those who have participated in other drug clinical trials and received trial drugs within 3 months before administration;
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]TPN171HA single 10 mg oral dose of [14C]TPN171H containing approximately 100 microcurie of [14C]-TPN171H. | Drug | [14C]TPN171H |
Primary outcome
Cmax - maximum observed plasma concentration
Time frame: From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H
Tmax - time at which Cmax occurs
Time frame: From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H
AUC0~t - area under the plasma concentration time curve from time zero to the last measurable concentration
Time frame: From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H
AUC0-∞ - area under the plasma concentration-time curve from time zero to infinity
Time frame: From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H
Total radioactivity in urine and faeces
Time frame: From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H
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 25 Feb 2021.
- 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.
Gangyi Liu principal investigator
Xuhui Central Hospital, Shanghai
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]TPN171H in people with Healthy Male Subjects, run by Vigonvita Life Sciences 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 5 inclusion and 16 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 25 Feb 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?
Cmax - maximum observed plasma concentration (time frame: From time zero up to 336 hours post-dose following oral administration of [14C]TPN171H). 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 25 Feb 2021.