The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets

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

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: TNP-2092 capsules; Drug: Rabeprazole sodium enteric-coated tablets; Drug: TNP-2092 capsules placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Rabeprazole sodium enteric-coated tablets + TNP-2092 capsules (n = 10)	Drug: TNP-2092 capsules; 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.; Other Names: Rifaquizinone; Drug: Rabeprazole sodium enteric-coated tablets; 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.
Placebo Comparator: Control Group; Rabeprazole sodium enteric-coated tablets + TNP-2092 capsules placebo (n = 10)	Drug: Rabeprazole sodium enteric-coated tablets; 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.; Drug: TNP-2092 capsules placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1 to Day 49
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	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.	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	Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration]

Collaborators and Investigators

• Sponsor: TenNor Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Actual): November 23, 2017
• Study Completion (Actual): November 23, 2017

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: TNP-2092-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No