A Phase 1 Study to Evaluate PK Profile of Multiple Oral A... | NCT06190340

NCT06190340

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
The First Hospital of Jilin University	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TNP-2092 capsules 100 mg	Experimental	Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15	Drug: TNP-2092 capsules
TNP-2092 capsules 300 mg	Experimental	Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15	Drug: TNP-2092 capsules
TNP-2092 capsules 600 mg	Experimental	Subjects received TNP-2092 capsules orally twice daily at the dose of 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	Drug: TNP-2092 capsules
Placebo	Placebo Comparator	Subjects received TNP-2092 placebo capsules 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	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
TNP-2092 capsules	Drug	Administration orally.	TNP-2092 capsules 100 mg TNP-2092 capsules 300 mg TNP-2092 capsules 600 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of TNP-2092 by Assessment of the Number of Adverse Events (AEs)	An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.	Day 1 to Day 49
Area Under the Plasma Concentration Versus Time Curve Over a Dosing Interval (AUC0-tau) on Day 1	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.	Day 1：Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after administration
Maximum Observed Plasma Concentration (Cmax) of TNP-2092 on Day 1	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.	Day 1：Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after administration
Time to Reach the Maximum Observed Plasma Concentration (Tmax) on Day 1	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.	Day 1：Before administration (within 60 minutes), 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after administration
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf) on Day 15

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Yanhua Ding, MD	The First Hospital of Jilin University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The First Hospital of Jilin University		Changchun	Jilin		China

Arm/Group Information

ID	Title	Description
FG000	TNP-2092 Capsules 100 mg	Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
FG001	TNP-2092 Capsules 300 mg	Subjects received TNP-2092 capsules orally twice daily at the dose of 300 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
FG002	TNP-2092 Capsules 600 mg	Subjects received TNP-2092 capsules orally twice daily at the dose of 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.
FG003	Placebo	Subjects received TNP-2092 placebo capsules 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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	TNP-2092 Capsules 100 mg	Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
BG001	TNP-2092 Capsules 300 mg

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Safety of TNP-2092 by Assessment of the Number of Adverse Events (AEs)

An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.

All subjects who have received at least one dose of study drug.

Posted

Number

participants

Day 1 to Day 49

ID	Title	Description
OG000	TNP-2092 Capsules 100 mg	Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.
OG001	TNP-2092 Capsules 300 mg

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	TNP-2092 Capsules 100 mg	Subjects received TNP-2092 capsules orally twice daily at the dose of 100 mg in the fed state for consecutive 14 days and received the last dose in the fed state on the morning of Day 15.