A Phase 1, Multiple Oral Administrations of TNP-2092 Capsules in Asymptomatic Healthy People With Helicobacter Pylori Infection

Helicobacter Pylori Infection Clinical Trial

Official title:

A Phase 1, Single-center, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Oral Administrations of TNP-2092 Capsules in Asymptomatic Healthy People With Helicobacter Pylori Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06190340
• Other study ID #: TNP-2092-03
• Status: Completed
• Phase: Phase 1
• Start date: November 7, 2016
• Est. completion date: August 15, 2017

Study information

• Verified date: January 2024
• Source: TenNor Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was a single-center, randomized, double-blind, placebo-controlled, dose-ascending multiple-dose-administration study. The aim of this study was to evaluate the safety, tolerability, and pharmacokinetic profile of TNP-2092 Capsules in asymptomatic healthy subjects with Helicobacter pylori infection, and to explore the preliminary efficacy of TNP-2092 Capsules in eradicating Helicobacter pylori.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 15, 2017
• Est. primary completion date: August 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• Those who are fully informed of and understand this study and have signed the Informed Consent Form.

• Those who are willing to follow and able to complete all the trial procedures.

• Female subjects of childbearing potential must agree to abstinence or take effective contraceptive measures during the trial and at least 70 days (10 weeks) after administration.

• Male subjects must agree to abstinence or use condoms as a contraceptive measure during the trial and at least 70 days (10 weeks) after administration.

• Sex: male or female.

• Age: 18-45 years, including 18 and 45 years.

• BMI: 19.0-26.0 kg/m2, including 19.0 and 26.0 kg/m2.

• Those who do not smoke, or have smoked less than 5 cigarettes per day within 3 months before screening; those 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; those 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 insignificance.

• Those with a positive 14C urea breath test (UBT) result.

Exclusion Criteria:

• Those with an allergic constitution, a history of allergic diseases or a history of drug allergy.

• Those with a history of alcohol or drug abuse in the past 10 years.

• Those who have donated blood within 3 months before enrollment.

• Those 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.

• Those who have taken any drug that changes the activity of liver enzymes 28 days before taking the investigational product or during the study.

• Those who have participated in any clinical trials within 3 months before enrollment.

• Those with a history of eradication of Helicobacter pylori.

• Those who are suffering or have suffered from digestive tract diseases, including digestive tract ulcer, etc.

• Those 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.

• Those whose blood pressure remains above 140/90 mmHg after retest.

• Pregnant or lactating women.

• Those who are HIV positive, syphilis positive, hepatitis B surface antigen positive, hepatitis C antibody positive.

• Those who have had beverages or foods containing methylxanthine (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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• TNP-2092 capsules
Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg, 300 mg, and 600 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
• Placebo
Subjects received Placebo orally twice daily in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TenNor Therapeutics Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration
Primary	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.	Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after administration
Primary	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