Clinical trial NCT06337604: The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Helicobacter Pylori Infection
Lead sponsor: TenNor Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Helicobacter pylori infection


Eligibility criteria: Inclusion Criteria:

* 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).
* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
timeFrame: 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
measure: Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-t)
timeFrame: 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
measure: Maximum Observed Plasma Concentration (Cmax) of TNP-2092
timeFrame: Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration]
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Day 1 to Day 49
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References: