Status:
COMPLETED
Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin
Lead Sponsor:
TenNor Therapeutics Inc.
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 Cl...
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 ho...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06551623
Start Date
August 26 2024
End Date
October 14 2024
Last Update
October 24 2024
Active Locations (1)
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1
The First Hospital of Jinlin University
Changchun, Jilin, China