Helicobacter Pylori InfectionPhase 1NCT06137573
Human Mass Balance and Biotransformation Study of [14C]TNP-2198
A Phase 1 study testing [14C]TNP-2198 in people with Helicobacter Pylori Infection, run by TenNor Therapeutics (Suzhou) Limited at 1 site in China.
Trial summary
The purpose of the study is to analyze absorption, metabolism, excretion, mass balance and biotransformation after a single oral dose of [14C]TNP-2198 in healthy male participants Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- [14C]TNP-2198
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2022to 1 Sep 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males.
- Age: 18-45 years old (inclusive).
- Body weight: Body mass index (BMI) within 19.0-26.0 kg/m2 (inclusive), and body weight no less than 50 kg.
- Those who have signed the Informed Consent Form voluntarily.
- The participant is able to communicate well with the investigator and to complete the study as specified in the protocol.
Who cannot join
- Those who meet any of the following criteria will not be included:
- Auxiliary examinations:
- Those with clinically significant abnormal physical examination, vital signs, clinical laboratory tests (hematology, blood biochemistry, coagulation, urinalysis, and fecal occult blood), thyroid function, 12-lead ECG, chest CT, or abdominal B ultrasonography (liver, gallbladder, pancreas, spleen and kidney).
- Those with positive hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody or syphilis antibody.
- Screening for SARS-CoV-2 infection: clinically significant abnormal C-reactive protein , or positive SARS-CoV-2 nucleic acid.
- Medication history:
Show all 28Show fewer
- Those who have used any drug that inhibits or induces hepatic drug-metabolizing enzymes within 30 days prior to screening.
- Those who have used any prescription drug, over-the-counter drug, Chinese herbal medicine or food supplement, such as vitamins and calcium supplements within 14 days prior to screening.
- Medical and surgical history:
- Those with a medical history of any clinically significant disease, or disease or condition that may affect the study results in the opinion of the investigator, including but not limited to the history of cardiovascular system, respiratory system, endocrine system, nervous system, gastrointestinal system, urinary system or hematological, immunological, mental and metabolic diseases.
- Those with a history of organic heart disease, cardiac failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsade de pointes, ventricular tachycardia, atrioventricular block, prolonged QT syndrome or prolonged QT syndrome symptoms and the family history (confirmed by heredity or sudden death in a close relative at a young age due to cardiac reasons).
- Those who have undergone any major surgery or incompletely healed surgical incision within 6 months prior to screening; major surgery includes, but is not limited to, any surgery with significant risk of haemorrhage, prolonged period of general anesthesia, or incisional biopsy or significant traumatic injury.
- Those with an allergic constitution, such as known history of allergy to two or more substances; or those who may be allergic to the investigational product, or its excipients as judged by the investigator.
- Those with haemorrhoids or perianal disease with regular/ongoing haematochezia, irritable bowel syndrome, or inflammatory bowel disease.
- Living habits:
- Those with habitual constipation or diarrhoea.
- Those with alcohol abuse or regular alcohol consumption within 6 months prior to screening, i.e., more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine); or alcohol breath test result ≥ 20 mg/dL at screening.
- Those who smoke more than 5 cigarettes per day or use nicotine-containing products habitually within 3 months prior to screening and are unable to abstain during the study.
- Those who have drug abuse or take soft drugs (such as marijuana) within 3 months prior to screening or take hard drugs (such as cocaine, amphetamines, phencyclidine, etc.) within 1 year prior to screening; or those who have positive urine drug test results at screening.
- Participants who habitually drink grapefruit juice or excessive tea, coffee and/or caffeine-containing beverages, and are unable to abstain during the study.
- Others:
- Those who need to work with long-term exposure to radioactive conditions; or those who have significant radiation exposure (≥ 2 chest/abdominal CT scans, or ≥ 3 other X-ray examinations) within 1 year before the study or have participated in radiopharmaceutical labeling trials.
- Those with a history of fear of needles or hemophobia, with difficulty in blood collection or unable to tolerate blood collection by venipuncture.
- Those who have participated in any other clinical trial (including drug and device clinical trials) within 3 months prior to screening.
- Those who have been vaccinated within 1 month prior to screening or plan to be vaccinated during the study.
- Those who plan to have children or donate sperm during the study and within 1 year after the completion of the study, or who do not agree that they and their spouses should take strict contraceptive measures during the study and within 1 year after the completion of the study (see Appendix 3 for details).
- Those who have lost blood or donated 400 mL of blood within 3 months prior to screening or received blood transfusion within 1 month.
- Participants who, in the opinion of the investigator, have any factors unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study of Absorption, Metabolism and Excretion of [14C]TNP-2198 in Healthy Adult Male Participants- Human Mass Balance and Biotransformation Study of [14C]TNP-2198
The purpose of the study is to analyze absorption, metabolism, excretion, mass balance and biotransformation after a single oral dose of [14C]TNP-2198 in healthy male participants
- Conditions
- Helicobacter Pylori Infection
- Being tested
- [14C]TNP-2198
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]TNP-2198Drug
Also called Rifasutenizol
600mg suspension containing 150μCi of [14C] TNP-2198
| Study group | Role | What they receive |
|---|---|---|
| [14C]TNP-2198 | Experimental | Participants will take a single dose of 600mg 150μCi of [14C]TNP-2198. Receives: Drug: [14C]TNP-2198 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative excretion rate of total radioactivity in excreta (urine and feces)
Quantitative analysis of total radioactivity in excreta after oral [14C] TNP-2198 in healthy volunteers
Measured: 0 hour(24 hours before administration) to 312 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results
Pharmacokinetics (PK) (AUC0-inf) for TNP-2198 and total radioactivity in plasma and whole blood
Assessment of pharmacokinetics of TNP-2198 and total radioactivity by measuring the concentration time curve from time zero extrapolated to infinity (AUC0-inf)
Measured: 0 hour (60 minutes before administration) to 216 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results
PK (AUC0-t) for TNP-2198 and total radioactivity in plasma and whole blood
Assessment of pharmacokinetics of TNP-2198 and total radioactivity by measuring the concentration time curve from time zero to the last measureable concentration (AUC0-t)
Measured: 0 hour (-60 minutes) before administration to 216 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results
PK (Cmax ) for TNP-2198 and total radioactivity in plasma and whole blood
Cmax (maximum observed concentration)
Measured: 0 hour (60 minutes before administration) to 216 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start12 Jul 2022
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- TenNor Therapeutics (Suzhou) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137573
- Sponsor's protocol ID
- TNP-2198-05
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Absorption, Metabolism and Excretion of [14C]TNP-2198 in Healthy Adult Male Participants- Human Mass Balance and Biotransformation Study of [14C]TNP-2198
- ClinicalTrials.gov ID
- NCT06137573
- Acronym / sponsor ID
- TNP-2198-05
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- TenNor Therapeutics (Suzhou) LimitedIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 18 Nov 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.
The purpose of the study is to analyze absorption, metabolism, excretion, mass balance and biotransformation after a single oral dose of [14C]TNP-2198 in healthy male participants
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]TNP-2198 | Experimental | Drug: [14C]TNP-2198Participants will take a single dose of 600mg 150μCi of [14C]TNP-2198. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult males.
- Age: 18-45 years old (inclusive).
- Body weight: Body mass index (BMI) within 19.0-26.0 kg/m2 (inclusive), and body weight no less than 50 kg.
- Those who have signed the Informed Consent Form voluntarily.
- The participant is able to communicate well with the investigator and to complete the study as specified in the protocol.
Key exclusion criteria (28 listed)
- Those with clinically significant abnormal physical examination, vital signs, clinical laboratory tests (hematology, blood biochemistry, coagulation, urinalysis, and fecal occult blood), thyroid function, 12-lead ECG, chest CT, or abdominal B ultrasonography (liver, gallbladder, pancreas, spleen and kidney).
- Those with positive hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody or syphilis antibody.
- Screening for SARS-CoV-2 infection: clinically significant abnormal C-reactive protein , or positive SARS-CoV-2 nucleic acid.
- Those who have used any drug that inhibits or induces hepatic drug-metabolizing enzymes within 30 days prior to screening.
- Those who have used any prescription drug, over-the-counter drug, Chinese herbal medicine or food supplement, such as vitamins and calcium supplements within 14 days prior to screening.
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]TNP-2198Also: Rifasutenizol600mg suspension containing 150μCi of [14C] TNP-2198 | Drug | [14C]TNP-2198 |
Primary outcome
Cumulative excretion rate of total radioactivity in excreta (urine and feces)
Time frame: 0 hour(24 hours before administration) to 312 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results
Quantitative analysis of total radioactivity in excreta after oral [14C] TNP-2198 in healthy volunteers
Pharmacokinetics (PK) (AUC0-inf) for TNP-2198 and total radioactivity in plasma and whole blood
Time frame: 0 hour (60 minutes before administration) to 216 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results
Assessment of pharmacokinetics of TNP-2198 and total radioactivity by measuring the concentration time curve from time zero extrapolated to infinity (AUC0-inf)
PK (AUC0-t) for TNP-2198 and total radioactivity in plasma and whole blood
Time frame: 0 hour (-60 minutes) before administration to 216 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results
Assessment of pharmacokinetics of TNP-2198 and total radioactivity by measuring the concentration time curve from time zero to the last measureable concentration (AUC0-t)
PK (Cmax ) for TNP-2198 and total radioactivity in plasma and whole blood
Time frame: 0 hour (60 minutes before administration) to 216 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results
Cmax (maximum observed concentration)
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 18 Nov 2023.
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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]TNP-2198 in people with Helicobacter Pylori Infection, run by TenNor Therapeutics (Suzhou) Limited 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 28 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 18 Nov 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?
Cumulative excretion rate of total radioactivity in excreta (urine and feces) (time frame: 0 hour(24 hours before administration) to 312 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results). The study lists 4 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 18 Nov 2023.