A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TNP-2198 Capsules in Asymptomatic Participants With Helicobacter Pylori Infection

Helicobacter Pylori Infection Clinical Trial

Official title:

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Oral Doses of TNP-2198 Capsules in Asymptomatic Subjects With Helicobacter Pylori Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06081712
• Other study ID #: TNP-2198-03
• Status: Completed
• Phase: Phase 1
• Start date: October 20, 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: October 2023
• Source: TenNor Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was a Phase 1, single-center, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and preliminary Helicobacter Pylori eradication efficacy of TNP-2198 capsules.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Those signed the informed consent form and fully understood the study contents, process and possible adverse reactions before participation in the study;

• Those are able to complete the study according to the requirements in the study protocol;

• Those (including the partner) are willing to use effective contraceptions from the screening up to 6 months after the last dose of study drug;

• Male and female subjects aged 18-55 years (inclusive);

• Male subjects no less than 50 kg and female subjects no less than 45 kg. Body mass index (BMI) = body weight (kg)/height2 (m2); BMI: 18-28kg/m2 (inclusive);

• Health status: no clinically significant history of heart, liver, kidney, digestive tract, nervous system, respiratory system diseases, mental disorders or metabolic abnormalities;

• Normal results or clinically insignificant abnormal results in physical examinations and vital sign assessment;

• Positive result of 14C urea breath test (UBT).

Exclusion Criteria:

• Average daily consumption of more than 5 cigarettes within 3 months before the study;

• Allergic constitution (allergy to multiple drugs and food);

• History of drug and/or alcohol abuse (mean consumption of = 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of liquor, or 100 mL of wine);

• History of Helicobacter Pylori eradication;

• Blood donation or massive blood loss (> 450 mL) within 3 months prior to screening;

• Using any drug that changes liver enzyme activity within 28 days prior to screening;

• Using any prescription drug, over-the-counter drug, any vitamin product, or herbal medicine within 14 days prior to screening;

• Taking special diet (including dragon fruit, mango, grapefruit, etc.) or strenuous exercise, or having other factors that affect drug absorption, distribution, metabolism, excretion, etc., within 2 weeks prior to screening;

• Significant changes in diet or exercise habits recently;

• Administration of any other study drug or participation in any drug clinical study within 3 months before administration of the study drug;

• With difficulty in swallowing or history of any gastrointestinal diseases that affect drug absorption;

• With any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers;

• With clinically significant ECG abnormalities;

• Female subjects who are lactating or having positive serum pregnancy test during screening or during the study;

• With symptoms or previous history of cardiovascular, digestive, respiratory, urinary, neurological, hematologic, immunological, endocrine system diseases, tumor, or psychiatric diseases;

• Clinically significant abnormalities in clinical laboratory tests, or other clinically significant findings (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immunological, psychiatric, or cardiovascular disease);

• Positive viral hepatitis (including hepatitis B and C), HIV antigen/antibody, treponema pallidum antibody;

• Acute illness or concomitant medication from the time of signing the informed consent to the time of study medication;

• Intake of chocolate, any caffeine- or xanthine-containing food or drink within 48 hours prior to administration of study drug;

• Intake of any alcohol-containing product within 48 hours before administration of study drug;

• Positive urine drug screening or history of drug abuse or drug addiction within the past 5 years;

• Other conditions that, in the opinion of the investigator, make the patient participating in this study inappropriate.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• TNP-2198
TNP-2198 capsules/placebo were administered orally twice daily (BID, at 7:00 ± 1 hour in the morning and 19:00 ± 1 hour in the evening) in the fasted state for consecutive 14 days, and the last dose was taken at 7:00 am (±1 hour) on Day 15 in the fasted state, and breakfast or dinner should not be taken within 30 minutes after each dose.
• TNP-2198 Placebo
TNP-2198 capsules/placebo were administered orally twice daily (BID, at 7:00 ± 1 hour in the morning and 19:00 ± 1 hour in the evening) in the fasted state for consecutive 14 days, and the last dose was taken at 7:00 am (±1 hour) on Day 15 in the fasted state, and breakfast or dinner should not be taken within 30 minutes after each dose.

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
TenNor Therapeutics (Suzhou) Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events(AEs)	The percentage of subjects with at least one AEs.	up to 17 days
Secondary	Area Under the Plasma Concentration-Time Curve from the First Dose Extrapolated to Infinity (AUC0-8)	Plasma concentrations of TNP-2198 were measured by a specific and validated assay. Plasma Pharmacokinetics (PK) parameters of TNP-2198 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.	Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15
Secondary	Area Under the Plasma Concentration-Time Curve from the First Dose to the Last Measurable Concentration (AUC 0-last)	Plasma concentrations of TNP-2198 were measured by a specific and validated assay. Plasma PK parameters of TNP-2198 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.	Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15
Secondary	Maximum Observed Plasma Concentration (Cmax) of TNP-2198	Plasma concentrations of TNP-2198 were measured by a specific and validated assay at specified time points	Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15