Helicobacter Pylori InfectionPhase 1NCT06337604
The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets
A Phase 1 study testing TNP-2092 capsules and Rabeprazole sodium enteric-coated tablets in people with Helicobacter Pylori Infection, run by TenNor Therapeutics Inc. at 1 site in China.
Trial summary
A phase 1, single-center, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and tolerability, pharmacokinetics, and preliminary efficacy of multiple administrations of TNP-2092 Capsules in combination with Rabeprazole Sodium Enteric-coated Tablets in asymptomatic healthy subjects with… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- TNP-2092 capsules and Rabeprazole sodium enteric-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2017to 23 Nov 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those who have signed the Informed Consent Form before the trial, and fully understand the trial content, procedures, and possible adverse reactions.
- Those who are able to complete the study according to the requirements of the protocol.
- Subjects (including male subjects) who agree to have no pregnancy plan and voluntarily take effective contraceptive measures from the screening date to 6 months after the last administration of the investigational product.
- Sex: male or female.
- Age: 18 - 50 years (inclusive).
- BMI: 18.0 - 28.0 kg/m2 (inclusive).
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- Subjects who do not smoke, or have smoked less than 5 cigarettes per day within 3 months before screening; subjects who do not drink alcohol, or have drunk less than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine) within 6 months before screening; subjects who have not smoked or drunk alcohol within 48 hours before admission to the study site.
- Subjects whose clinical laboratory test results are within the normal range or whose test results are abnormal but judged by the investigator to be of no clinical significance.
- Subjects with a positive 14C urea breath test(UBT) result.
Who cannot join
- Subjects with an allergic constitution, a history of allergic diseases or a history of drug allergy.
- Subjects with a history of alcohol or drug abuse in the past 10 years.
- Subjects who have donated blood within 3 months before enrollment.
- Subjects with regular use of any prescription/over-the-counter drugs, including vitamins, minerals, nutritional supplements or herbs, within 2 weeks before enrollment and during the study period.
- Subjects who have taken any drug that changes the activity of liver enzymes 28 days before taking the investigational product or during the study.
- Subjects who have participated in any clinical trials within 3 months before enrollment.
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- Subjects with a history of eradication of Helicobacter pylori.
- Subjects who are suffering or have suffered from digestive tract diseases, including digestive tract ulcer, etc.
- Subjects with symptoms or past medical history of cardiovascular, respiratory, urinary, neurological, blood, immune, endocrine system diseases or tumor, mental illness, or any situation which, in the opinion of the investigator, may threaten the safety of the subjects or affect the correctness of the trial results.
- Subjects whose blood pressure remains above 150/95 mmHg after retest.
- Pregnant or lactating women.
- Subjects who are HIV positive, syphilis positive, hepatitis B surface antigen positive, hepatitis C antibody positive.
- Subjects who have had caffeinated beverages or foods (coffee, tea, coke, chocolate and energy drinks), grapefruit (fruit juice) and alcohol within 48 hours (2 days) before the clinical study.
- Other circumstances deemed by the investigator to be unsuitable for the subject to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-center, Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Administrations of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets in Asymptomatic Healthy Subjects With Helicobacter Pylori Infection
A phase 1, single-center, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and tolerability, pharmacokinetics, and preliminary efficacy of multiple administrations of TNP-2092 Capsules in combination with Rabeprazole Sodium Enteric-coated Tablets in asymptomatic healthy subjects with Helicobacter pylori infection
- Conditions
- Helicobacter Pylori Infection
- Being tested
- TNP-2092 capsules, TNP-2092 capsules placebo, Rabeprazole sodium enteric-coated tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNP-2092 capsulesDrug
Also called Rifaquizinone
TNP-2092 capsules 300 mg twice daily(BID): Taken with 240 mL of warm water 30 minutes (± 5 minutes) after breakfast and dinner, with a 12-hour interval between the two doses. Such administration will last 14 consecutive days. The last administration will be on the morning of Day 15. There will be a total of 29 doses.
TNP-2092 capsules placeboDrug
TNP-2092 Capsules Placebo 300 mg BID : Taken with 240 mL of warm water 30 minutes (± 5 minutes) after breakfast and dinner, with a 12-hour interval between the two doses. Such administration will last 14 consecutive days. The last administration will be on the morning of Day 15. There will be a total of 29 doses.
Rabeprazole sodium enteric-coated tabletsDrug
Rabeprazole sodium enteric-coated tablets (20 mg BID): Taken with 240 mL of warm water 30 minutes (± 5 minutes) before breakfast and dinner for 14 consecutive days. The last administration will be on the morning of Day 15. There will be a total of 29 doses.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Rabeprazole sodium enteric-coated tablets + TNP-2092 capsules (n = 10) Receives: Drug: TNP-2092 capsules; Drug: Rabeprazole sodium enteric-coated tablets |
| Control Group | Placebo comparator | Rabeprazole sodium enteric-coated tablets + TNP-2092 capsules placebo (n = 10) Receives: Drug: TNP-2092 capsules placebo; Drug: Rabeprazole sodium enteric-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods
Measured: Within 15 minutes before the morning dose of Rabeprazole Sodium Enteric-coated Tablets, and 20 minutes, 50 minutes, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 8, 10 and 12 hours after the morning dose of Rabeprazole Sodium Enteric-coated Tablets
Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-t)
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Within 15 minutes before the morning dose of Rabeprazole Sodium Enteric-coated Tablets, and 20 minutes, 50 minutes, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 8, 10 and 12 hours after the morning dose of Rabeprazole Sodium Enteric-coated Tablets
Maximum Observed Plasma Concentration (Cmax) of TNP-2092
Plasma concentrations of TNP-2092 were measured by a specific and validated assay at specified time points
Measured: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration]
Percentage of Participants With Adverse Events (AEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events
Measured: Day 1 to Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start10 Oct 2017
- Primary completion23 Nov 2017
- Study completion23 Nov 2017
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- TenNor Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337604
- Sponsor's protocol ID
- TNP-2092-04
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-center, Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Administrations of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets in Asymptomatic Healthy Subjects With Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT06337604
- Acronym / sponsor ID
- TNP-2092-04
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- TenNor Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 23 Nov 2017 (actual)
- Study completion
- 23 Nov 2017 (actual)
- First posted
- 29 Mar 2024 (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.
A phase 1, single-center, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and tolerability, pharmacokinetics, and preliminary efficacy of multiple administrations of TNP-2092 Capsules in combination with Rabeprazole Sodium Enteric-coated Tablets in asymptomatic healthy subjects with Helicobacter pylori infection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: TNP-2092 capsules, Drug: Rabeprazole sodium enteric-coated tabletsRabeprazole sodium enteric-coated tablets + TNP-2092 capsules (n = 10) |
| Control Group | Placebo comparator | Drug: TNP-2092 capsules placebo, Drug: Rabeprazole sodium enteric-coated tabletsRabeprazole sodium enteric-coated tablets + TNP-2092 capsules placebo (n = 10) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Those who have signed the Informed Consent Form before the trial, and fully understand the trial content, procedures, and possible adverse reactions.
- Those who are able to complete the study according to the requirements of the protocol.
- Subjects (including male subjects) who agree to have no pregnancy plan and voluntarily take effective contraceptive measures from the screening date to 6 months after the last administration of the investigational product.
- Sex: male or female.
- Age: 18 - 50 years (inclusive).
Key exclusion criteria (14 listed)
- Subjects with an allergic constitution, a history of allergic diseases or a history of drug allergy.
- Subjects with a history of alcohol or drug abuse in the past 10 years.
- Subjects who have donated blood within 3 months before enrollment.
- Subjects with regular use of any prescription/over-the-counter drugs, including vitamins, minerals, nutritional supplements or herbs, within 2 weeks before enrollment and during the study period.
- Subjects who have taken any drug that changes the activity of liver enzymes 28 days before taking the investigational product or during the study.
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 |
|---|---|---|
| TNP-2092 capsulesAlso: RifaquizinoneTNP-2092 capsules 300 mg twice daily(BID): Taken with 240 mL of warm water 30 minutes (± 5 minutes) after breakfast and dinner, with a 12-hour interval between the two doses. Such administration will last 14 consecutive days. The last administration will be on the morning of Day 15. There will be a total of 29 doses. | Drug | Study Group |
| TNP-2092 capsules placeboTNP-2092 Capsules Placebo 300 mg BID : Taken with 240 mL of warm water 30 minutes (± 5 minutes) after breakfast and dinner, with a 12-hour interval between the two doses. Such administration will last 14 consecutive days. The last administration will be on the morning of Day 15. There will be a total of 29 doses. | Drug | Control Group |
| Rabeprazole sodium enteric-coated tabletsRabeprazole sodium enteric-coated tablets (20 mg BID): Taken with 240 mL of warm water 30 minutes (± 5 minutes) before breakfast and dinner for 14 consecutive days. The last administration will be on the morning of Day 15. There will be a total of 29 doses. | Drug | Control Group, Study Group |
Primary outcome
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
Time frame: Within 15 minutes before the morning dose of Rabeprazole Sodium Enteric-coated Tablets, and 20 minutes, 50 minutes, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 8, 10 and 12 hours after the morning dose of Rabeprazole Sodium Enteric-coated Tablets
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods
Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-t)
Time frame: Within 15 minutes before the morning dose of Rabeprazole Sodium Enteric-coated Tablets, and 20 minutes, 50 minutes, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 8, 10 and 12 hours after the morning dose of Rabeprazole Sodium Enteric-coated Tablets
Plasma concentrations of TNP-2092 were measured by a specific and validated assay. Plasma PK parameters of TNP-2092 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Maximum Observed Plasma Concentration (Cmax) of TNP-2092
Time frame: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration]
Plasma concentrations of TNP-2092 were measured by a specific and validated assay at specified time points
Percentage of Participants With Adverse Events (AEs)
Time frame: Day 1 to Day 49
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events
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 1 Apr 2024.
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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 TNP-2092 capsules and Rabeprazole sodium enteric-coated tablets in people with Helicobacter Pylori Infection, run by TenNor Therapeutics Inc. 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 9 inclusion and 14 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 1 Apr 2024. 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. Some participants in this study may receive a placebo. 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?
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) (time frame: Within 15 minutes before the morning dose of Rabeprazole Sodium Enteric-coated Tablets, and 20 minutes, 50 minutes, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 8, 10 and 12 hours after the morning dose of Rabeprazole Sodium Enteric-coated Tablets). 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 1 Apr 2024.