Helicobacter Pylori InfectionPhase 1NCT06551623
Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin
A Phase 1 study testing Midazolam, Clarithromycin and TNP-2198 in people with Helicobacter Pylori Infection, run by TenNor Therapeutics Inc. at 1 site in China.
Trial summary
This is a single center, open label, drug-drug interaction, Phase 1 study of TNP-2198 in approximately 32 healthy participants, includes 2 cohorts (16 participants per cohort): Midazolam cohort and Clarithromycin cohort. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Midazolam, Clarithromycin and TNP-2198
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2024to 14 Oct 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be able to provide written Informed consent forms (ICF) and fully understand the study procedures and potential AEs.
- Be able to comply with all protocol requirements.
- Willing to voluntarily take effective contraceptive measures from signing the ICF to 3 months after the last dose of investigational product, and male subjects must refrain from sperm donation during this period.
- Male or female, 18 to 55 years of age, inclusive.
- Have a body mass index (BMI) 18 to 28 kg/m2, inclusive, and body weight ≥ 50 kg for male or ≥ 45 kg for female.
- The results of physical examination and vital signs are normal or abnormal but without clinical significance.
Who cannot join
- Have a history of allergy to the investigational products (TNP-2198, midazolam [Midazolam cohort] or clarithromycin [Clarithromycin cohort]), and/or allergic constitution (such as allergic to multiple drugs, food or pollen, or prone to allergic reactions without knowing the causes of allergy).
- Have abnormal laboratory tests with clinical significance, or have dysphagia, or have diseases that can affect drug absorption or excretion within 6 months before screening, or other clinical findings within 12 months before screening indicating clinically significant diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
- Have an abnormal result of ECG with clinical significance at screening/baseline.
- Have a positive test result for Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), AIDS antibody or Treponema pallidum antibody at screening/baseline.
- Female participants have a positive result for pregnancy test at screening or admission or are lactating.
- Have a positive result for orthostatic hypotension at screening, or have a history of orthostatic hypotension, when screening for Midazolam cohort.
Show all 19Show fewer
- Have used CYP3A inducers or inhibitors (such as clarithromycin, erythromycin, verapamil, diltiazem, ketoconazole, itraconazole, ritonavir, etc.), P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitors or inducers (such as itraconazole, ketoconazole or dronedarone, etc.) within 30 days before screening.
- Participants who must take prescription or non-prescription drugs (including vitamins and dietary or herbal supplements, etc.) within 7 days or 5 half-lives (whichever is longer) before the administration of investigational products or throughout the study, unless the investigator considers that the drug will not interfere with the study. Any exceptions will be discussed with the sponsor case-by-case and the reasons will be documented.
- Participants enrolled in other clinical trials, or received other investigational products, or used medical devices within 3 months before the administration of investigational products in this study, or 5 half-lives of other investigational products, or twice the duration of biological effect of other investigational products (whichever is longer).
- Smoke more than 5 cigarettes or equivalent cigarettes per day on average within 3 months prior to the first dose, or unable to stop smoking during the study.
- Have alcohol abuse within 6 months before screening, that is, drink more than 14 units of alcohol per week on average (1 unit = 285 mL of beer, or 45 mL of 40% liquor, or 100 mL of wine), or cannot stop drinking any alcohol-containing products during the study, or drinking or taking any alcohol-containing products within 48 hours before the first dose, or alcohol breath test result is positive at screening/baseline.
- Have a history of drug abuse within 6 months prior to screening or have positive results for drug screening tests at baseline.
- Have received live or attenuated vaccines within 1 month before screening, or plan to receive live or attenuated vaccines during the study.
- Have a blood donation more than 400 mL within 3 months before the first dose of investigational products or have received a blood transfusion within 1 month before screening.
- Have special food (such as chocolate, dragon fruit, mango, grapefruit, any diet containing caffeine or xanthine) or be involved in strenuous exercise within 48 hours before the first dose of investigational product.
- Have an acute disease or concomitant medication from the screening period to before taking the investigational products.
- Have acute angle-closure glaucoma or open angle glaucoma without effective treatment at screening for Midazolam cohort.
- Have a history of congenital or acquired QT prolongation, or ventricular arrhythmia history at screening for Clarithromycin cohort.
- The investigator considers that the participant is unable to comply with all study procedures, or has other conditions that are not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open Label, Phase 1 Study in Healthy Participants to Investigate the Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin
This is a single center, open label, drug-drug interaction, Phase 1 study of TNP-2198 in approximately 32 healthy participants, includes 2 cohorts (16 participants per cohort): Midazolam cohort and Clarithromycin cohort. Midazolam cohort will evaluate the effect of multiple oral doses of TNP-2198 capsules on the pharmacokinetics (PK) parameters of a single oral dose of midazolam, a cytochrome P-450 (CYP) 3A sensitive substrate, in healthy participants; Clarithromycin cohort will evaluate the effect of multiple oral doses of clarithromycin tablets, a strong CYP3A and P-gp inhibitor, on the PK parameters of multiple oral doses of TNP-2198 in healthy participants.
Read the detailed description
Midazolam cohort: Midazolam oral solution will be administered orally at a dose of 2 mg once a day within 0.5 hours after breakfast on Day 1, and administered following TNP-2198 capsules within 0.5 hours after breakfast on Day 10. TNP 2198 capsules will be administered orally at a dose of 400 mg twice a day, within 0.5 hours after breakfast and dinner, from Day 3 to Day 11. PK blood sampling and safety tests were performed at specified time points.
Clarithromycin cohort: TNP-2198 capsules will be administered orally at a dose of 400 mg twice a day, within 0.5 hours after breakfast and dinner, from Day 1 to Day 7, and within 0.5 hours after breakfast on Day 8. Clarithromycin tablets will be administered at a dose of 0.5 g twice a day, within 0.5 hours after breakfast and dinner, from Day 16 to Day 25. TNP-2198 capsules will be administered within 0.5 hours after breakfast and dinner, followed by clarithromycin tablets, from Day 16 to Day 22. TNP-2198 capsules will be administrated within 0.5 hours after breakfast, followed by clarithromycin tablets on Day 23. PK blood sample collection and safety tests were performed at specified time points.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Midazolam, Clarithromycin, TNP-2198
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Midazolam Oral Solution 2 mg
ClarithromycinDrug
Clarithromycin tablets 0.5 g
TNP-2198Drug
TNP-2198 Capsules 400 mg
| Study group | Role | What they receive |
|---|---|---|
| Midazolam cohort | Experimental | Midazolam Oral Solution will be given orally once daily within 0.5 hours after breakfast on Day 1 and Day 10.
TNP-2198 Capsules will be given orally twice daily within 0.5 hours after breakfast and dinner from Day 3 to Day 11. Receives: Drug: Midazolam; Drug: TNP-2198 |
| Clarithromycin cohort | Experimental | Clarithromycin tablets will be given orally within 0.5 hours after breakfast and dinner from Day 16 to Day 25.
TNP-2198 Capsules will be given orally twice daily within 0.5 hours after breakfast and dinner from Day 1 to Day 7 and from Day16 to Day 22, and once daily within 0.5 hours after breakfast on Day 8 and Day 23. Receives: Drug: Clarithromycin; Drug: TNP-2198 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Midazolam cohort: PK parameters of midazolam-Area under the plasma concentration versus time curve (AUC0-t)
Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration (AUC0-t)
Measured: Within 1 hour prior to midazolam dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours following midazolam dosing on Day 1 and Day 10, respectively.
Midazolam cohort: PK parameters of midazolam-Area under the plasma concentration versus time curve (AUC0-∞)
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-∞)
Measured: Within 1 hour prior to midazolam dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours following midazolam dosing on Day 1 and Day 10, respectively.
Midazolam cohort: PK parameters of midazolam-Maximum observed plasma concentration (Cmax)
Maximum observed plasma concentration (Cmax)
Measured: Within 1 hour prior to midazolam dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours following midazolam dosing on Day 1 and Day 10, respectively.
Clarithromycin cohort: PK parameters of TNP-2198-Area under the plasma concentration versus time curve(AUC0-t)
Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration
Measured: Within 1 hour prior to TNP-2198 dosing and at 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours following TNP-2198 dosing on Day 8 and Day 23, respectively.
Clarithromycin cohort: PK parameters of TNP-2198-Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-∞)
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity
Measured: Within 1 hour prior to TNP-2198 dosing and at 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours following TNP-2198 dosing on Day 8 and Day 23, respectively.
Clarithromycin cohort: PK parameters of TNP-2198-Maximum observed plasma concentration (Cmax)
Cmax
Measured: Within 1 hour prior to TNP-2198 dosing and at 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours following TNP-2198 dosing on Day 8 and Day 23, respectively.
Secondary outcomes (6)
Midazolam cohort: 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 12
Clarithromycin cohort: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 26
Midazolam cohort: PK parameters of midazolam Time to Maximum Plasma Concentration (Tmax)
Time to Maximum Plasma Concentration (Tmax)
Measured: Within 1 hour prior to midazolam dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours following midazolam dosing on Day 1 and Day 10, respectively.
Midazolam cohort: PK parameters of midazolam Terminal Elimination Half-life (T1/2)
Terminal Elimination Half-life (T1/2)
Measured: Within 1 hour prior to midazolam dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours following midazolam dosing on Day 1 and Day 10, respectively.
Clarithromycin cohort: PK parameters of TNP-2198 Time to Maximum Plasma Concentration (Tmax)
Time to Maximum Plasma Concentration (Tmax)
Measured: Within 1 hour prior to TNP-2198 dosing and at 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours following TNP-2198 dosing on Day 8 and Day 23, respectively.
Clarithromycin cohort: PK parameters of TNP-2198 Terminal Elimination Half-life (T1/2)
Terminal Elimination Half-life (T1/2)
Measured: Within 1 hour prior to TNP-2198 dosing and at 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours following TNP-2198 dosing on Day 8 and Day 23, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start26 Aug 2024
- Primary completion14 Oct 2024
- Study completion14 Oct 2024
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- TenNor Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaojiao Li, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551623
- Sponsor's protocol ID
- TNP-2198-10
- Status last verified
- Oct 2024
- First submitted
- 9 Aug 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label, Phase 1 Study in Healthy Participants to Investigate the Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin
- ClinicalTrials.gov ID
- NCT06551623
- Acronym / sponsor ID
- TNP-2198-10
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- TenNor Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 13 Aug 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.
This is a single center, open label, drug-drug interaction, Phase 1 study of TNP-2198 in approximately 32 healthy participants, includes 2 cohorts (16 participants per cohort): Midazolam cohort and Clarithromycin cohort. Midazolam cohort will evaluate the effect of multiple oral doses of TNP-2198 capsules on the pharmacokinetics (PK) parameters of a single oral dose of midazolam, a cytochrome P-450 (CYP) 3A sensitive substrate, in healthy participants; Clarithromycin cohort will evaluate the effect of multiple oral doses of clarithromycin tablets, a strong CYP3A and P-gp inhibitor, on the PK parameters of multiple oral doses of TNP-2198 in healthy participants.
Detailed description
Midazolam cohort: Midazolam oral solution will be administered orally at a dose of 2 mg once a day within 0.5 hours after breakfast on Day 1, and administered following TNP-2198 capsules within 0.5 hours after breakfast on Day 10. TNP 2198 capsules will be administered orally at a dose of 400 mg twice a day, within 0.5 hours after breakfast and dinner, from Day 3 to Day 11. PK blood sampling and safety tests were performed at specified time points.
Clarithromycin cohort: TNP-2198 capsules will be administered orally at a dose of 400 mg twice a day, within 0.5 hours after breakfast and dinner, from Day 1 to Day 7, and within 0.5 hours after breakfast on Day 8. Clarithromycin tablets will be administered at a dose of 0.5 g twice a day, within 0.5 hours after breakfast and dinner, from Day 16 to Day 25. TNP-2198 capsules will be administered within 0.5 hours after breakfast and dinner, followed by clarithromycin tablets, from Day 16 to Day 22. TNP-2198 capsules will be administrated within 0.5 hours after breakfast, followed by clarithromycin tablets on Day 23. PK blood sample collection and safety tests were performed at specified time points.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midazolam cohort | Experimental | Drug: Midazolam, Drug: TNP-2198Midazolam Oral Solution will be given orally once daily within 0.5 hours after breakfast on Day 1 and Day 10. TNP-2198 Capsules will be given orally twice daily within 0.5 hours after breakfast and dinner from Day 3 to Day 11. |
| Clarithromycin cohort | Experimental | Drug: Clarithromycin, Drug: TNP-2198Clarithromycin tablets will be given orally within 0.5 hours after breakfast and dinner from Day 16 to Day 25. TNP-2198 Capsules will be given orally twice daily within 0.5 hours after breakfast and dinner from Day 1 to Day 7 and from Day16 to Day 22, and once daily within 0.5 hours after breakfast on Day 8 and Day 23. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Be able to provide written Informed consent forms (ICF) and fully understand the study procedures and potential AEs.
- Be able to comply with all protocol requirements.
- Willing to voluntarily take effective contraceptive measures from signing the ICF to 3 months after the last dose of investigational product, and male subjects must refrain from sperm donation during this period.
- Male or female, 18 to 55 years of age, inclusive.
- Have a body mass index (BMI) 18 to 28 kg/m2, inclusive, and body weight ≥ 50 kg for male or ≥ 45 kg for female.
Key exclusion criteria (19 listed)
- Have a history of allergy to the investigational products (TNP-2198, midazolam [Midazolam cohort] or clarithromycin [Clarithromycin cohort]), and/or allergic constitution (such as allergic to multiple drugs, food or pollen, or prone to allergic reactions without knowing the causes of allergy).
- Have abnormal laboratory tests with clinical significance, or have dysphagia, or have diseases that can affect drug absorption or excretion within 6 months before screening, or other clinical findings within 12 months before screening indicating clinically significant diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
- Have an abnormal result of ECG with clinical significance at screening/baseline.
- Have a positive test result for Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), AIDS antibody or Treponema pallidum antibody at screening/baseline.
- Female participants have a positive result for pregnancy test at screening or admission or are lactating.
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 |
|---|---|---|
| MidazolamMidazolam Oral Solution 2 mg | Drug | Midazolam cohort |
| ClarithromycinClarithromycin tablets 0.5 g | Drug | Clarithromycin cohort |
| TNP-2198TNP-2198 Capsules 400 mg | Drug | Clarithromycin cohort, Midazolam cohort |
Primary outcome
Midazolam cohort: PK parameters of midazolam-Area under the plasma concentration versus time curve (AUC0-t)
Time frame: Within 1 hour prior to midazolam dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours following midazolam dosing on Day 1 and Day 10, respectively.
Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration (AUC0-t)
Midazolam cohort: PK parameters of midazolam-Area under the plasma concentration versus time curve (AUC0-∞)
Time frame: Within 1 hour prior to midazolam dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours following midazolam dosing on Day 1 and Day 10, respectively.
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-∞)
Midazolam cohort: PK parameters of midazolam-Maximum observed plasma concentration (Cmax)
Time frame: Within 1 hour prior to midazolam dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours following midazolam dosing on Day 1 and Day 10, respectively.
Maximum observed plasma concentration (Cmax)
Clarithromycin cohort: PK parameters of TNP-2198-Area under the plasma concentration versus time curve(AUC0-t)
Time frame: Within 1 hour prior to TNP-2198 dosing and at 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours following TNP-2198 dosing on Day 8 and Day 23, respectively.
Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration
Clarithromycin cohort: PK parameters of TNP-2198-Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-∞)
Time frame: Within 1 hour prior to TNP-2198 dosing and at 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours following TNP-2198 dosing on Day 8 and Day 23, respectively.
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity
Clarithromycin cohort: PK parameters of TNP-2198-Maximum observed plasma concentration (Cmax)
Time frame: Within 1 hour prior to TNP-2198 dosing and at 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours following TNP-2198 dosing on Day 8 and Day 23, respectively.
Cmax
6 secondary outcomes
Midazolam cohort: Percentage of Participants With Adverse Events (AEs)
Time frame: Day 1 to Day 12
Clarithromycin cohort:Percentage of Participants With Adverse Events (AEs)
Time frame: Day 1 to Day 26
Midazolam cohort: PK parameters of midazolam Time to Maximum Plasma Concentration (Tmax)
Time frame: Within 1 hour prior to midazolam dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours following midazolam dosing on Day 1 and Day 10, respectively.
Midazolam cohort: PK parameters of midazolam Terminal Elimination Half-life (T1/2)
Time frame: Within 1 hour prior to midazolam dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours following midazolam dosing on Day 1 and Day 10, respectively.
Clarithromycin cohort: PK parameters of TNP-2198 Time to Maximum Plasma Concentration (Tmax)
Time frame: Within 1 hour prior to TNP-2198 dosing and at 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours following TNP-2198 dosing on Day 8 and Day 23, respectively.
Clarithromycin cohort: PK parameters of TNP-2198 Terminal Elimination Half-life (T1/2)
Time frame: Within 1 hour prior to TNP-2198 dosing and at 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, and 72 hours following TNP-2198 dosing on Day 8 and Day 23, respectively.
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 24 Oct 2024.
- 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.
Xiaojiao Li principal investigator
The First Hospital of Jilin University
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 Midazolam, Clarithromycin and TNP-2198 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 6 inclusion and 19 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 24 Oct 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. 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?
Midazolam cohort: PK parameters of midazolam-Area under the plasma concentration versus time curve (AUC0-t) (time frame: Within 1 hour prior to midazolam dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours following midazolam dosing on Day 1 and Day 10, respectively.). The study lists 6 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 24 Oct 2024.