A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TNP-2198 Capsules in Asymptomatic Participants With Helicobacter Pylori Infection
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Multiple Ascending Doses Cohort 1 TNP-2198 Capsules 200mg, BID, for 14days |
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.
Other Names:
Drug: 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.
|
| Experimental: Multiple Ascending Doses Cohort 2 TNP-2198 Capsules 400mg,BID, for 14days |
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.
Other Names:
Drug: 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.
|
| Experimental: Multiple Ascending Doses Cohort 3 TNP-2198 Capsules 600mg,BID, for 14days |
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.
Other Names:
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- Incidence of Adverse Events(AEs) [up to 17 days]
The percentage of subjects with at least one AEs.
Secondary Outcome Measures
- Area Under the Plasma Concentration-Time Curve from the First Dose Extrapolated to Infinity (AUC0-∞) [Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15]
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.
- Area Under the Plasma Concentration-Time Curve from the First Dose to the Last Measurable Concentration (AUC 0-last) [Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15]
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.
- Maximum Observed Plasma Concentration (Cmax) of TNP-2198 [Day 1,Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15]
Plasma concentrations of TNP-2198 were measured by a specific and validated assay at specified time points
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Hospital of Jilin University | Changchun | Jilin | China |
Sponsors and Collaborators
- TenNor Therapeutics (Suzhou) Limited
Investigators
- Study Director: TenNor Clinical Trials, TenNor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TNP-2198-03