Human Mass Balance and Biotransformation Study of [14C]TNP-2198

November 15, 2023 updated by: TenNor Therapeutics (Suzhou) Limited

A Clinical Study of Absorption, Metabolism and Excretion of [14C]TNP-2198 in Healthy Adult Male Participants- Human Mass Balance and Biotransformation Study of [14C]TNP-2198

The purpose of the study is to analyze absorption, metabolism, excretion, mass balance and biotransformation after a single oral dose of [14C]TNP-2198 in healthy male participants

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adult males.
  • Age: 18-45 years old (inclusive).
  • Body weight: Body mass index (BMI) within 19.0-26.0 kg/m2 (inclusive), and body weight no less than 50 kg.
  • Those who have signed the Informed Consent Form voluntarily.
  • The participant is able to communicate well with the investigator and to complete the study as specified in the protocol.

Exclusion Criteria:

Those who meet any of the following criteria will not be included:

Auxiliary examinations:

  • Those with clinically significant abnormal physical examination, vital signs, clinical laboratory tests (hematology, blood biochemistry, coagulation, urinalysis, and fecal occult blood), thyroid function, 12-lead ECG, chest CT, or abdominal B ultrasonography (liver, gallbladder, pancreas, spleen and kidney).
  • Those with positive hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody or syphilis antibody.
  • Screening for SARS-CoV-2 infection: clinically significant abnormal C-reactive protein , or positive SARS-CoV-2 nucleic acid.

Medication history:

  • Those who have used any drug that inhibits or induces hepatic drug-metabolizing enzymes within 30 days prior to screening.
  • Those who have used any prescription drug, over-the-counter drug, Chinese herbal medicine or food supplement, such as vitamins and calcium supplements within 14 days prior to screening.

Medical and surgical history:

  • Those with a medical history of any clinically significant disease, or disease or condition that may affect the study results in the opinion of the investigator, including but not limited to the history of cardiovascular system, respiratory system, endocrine system, nervous system, gastrointestinal system, urinary system or hematological, immunological, mental and metabolic diseases.
  • Those with a history of organic heart disease, cardiac failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsade de pointes, ventricular tachycardia, atrioventricular block, prolonged QT syndrome or prolonged QT syndrome symptoms and the family history (confirmed by heredity or sudden death in a close relative at a young age due to cardiac reasons).
  • Those who have undergone any major surgery or incompletely healed surgical incision within 6 months prior to screening; major surgery includes, but is not limited to, any surgery with significant risk of haemorrhage, prolonged period of general anesthesia, or incisional biopsy or significant traumatic injury.
  • Those with an allergic constitution, such as known history of allergy to two or more substances; or those who may be allergic to the investigational product, or its excipients as judged by the investigator.
  • Those with haemorrhoids or perianal disease with regular/ongoing haematochezia, irritable bowel syndrome, or inflammatory bowel disease.

Living habits:

  • Those with habitual constipation or diarrhoea.
  • Those with alcohol abuse or regular alcohol consumption within 6 months prior to screening, i.e., more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine); or alcohol breath test result ≥ 20 mg/dL at screening.
  • Those who smoke more than 5 cigarettes per day or use nicotine-containing products habitually within 3 months prior to screening and are unable to abstain during the study.
  • Those who have drug abuse or take soft drugs (such as marijuana) within 3 months prior to screening or take hard drugs (such as cocaine, amphetamines, phencyclidine, etc.) within 1 year prior to screening; or those who have positive urine drug test results at screening.
  • Participants who habitually drink grapefruit juice or excessive tea, coffee and/or caffeine-containing beverages, and are unable to abstain during the study.

Others:

  • Those who need to work with long-term exposure to radioactive conditions; or those who have significant radiation exposure (≥ 2 chest/abdominal CT scans, or ≥ 3 other X-ray examinations) within 1 year before the study or have participated in radiopharmaceutical labeling trials.
  • Those with a history of fear of needles or hemophobia, with difficulty in blood collection or unable to tolerate blood collection by venipuncture.
  • Those who have participated in any other clinical trial (including drug and device clinical trials) within 3 months prior to screening.
  • Those who have been vaccinated within 1 month prior to screening or plan to be vaccinated during the study.
  • Those who plan to have children or donate sperm during the study and within 1 year after the completion of the study, or who do not agree that they and their spouses should take strict contraceptive measures during the study and within 1 year after the completion of the study (see Appendix 3 for details).
  • Those who have lost blood or donated 400 mL of blood within 3 months prior to screening or received blood transfusion within 1 month.
  • Participants who, in the opinion of the investigator, have any factors unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: [14C]TNP-2198
Participants will take a single dose of 600mg 150μCi of [14C]TNP-2198.
Drug: [14C]TNP-2198
600mg suspension containing 150μCi of [14C] TNP-2198
Other Names:
  • Rifasutenizol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cumulative excretion rate of total radioactivity in excreta (urine and feces)
Time Frame: 0 hour(24 hours before administration) to 312 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results
Quantitative analysis of total radioactivity in excreta after oral [14C] TNP-2198 in healthy volunteers
0 hour(24 hours before administration) to 312 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results
Pharmacokinetics (PK) (AUC0-inf) for TNP-2198 and total radioactivity in plasma and whole blood
Time Frame: 0 hour (60 minutes before administration) to 216 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results
Assessment of pharmacokinetics of TNP-2198 and total radioactivity by measuring the concentration time curve from time zero extrapolated to infinity (AUC0-inf)
0 hour (60 minutes before administration) to 216 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results
PK (AUC0-t) for TNP-2198 and total radioactivity in plasma and whole blood
Time Frame: 0 hour (-60 minutes) before administration to 216 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results
Assessment of pharmacokinetics of TNP-2198 and total radioactivity by measuring the concentration time curve from time zero to the last measureable concentration (AUC0-t)
0 hour (-60 minutes) before administration to 216 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results
PK (Cmax ) for TNP-2198 and total radioactivity in plasma and whole blood
Time Frame: 0 hour (60 minutes before administration) to 216 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results
Cmax (maximum observed concentration)
0 hour (60 minutes before administration) to 216 hours after administration. Periodic detection performed, and the collection of biological samples can be judged according to the detection results

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TenNor Therapeutics (Suzhou) Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TNP-2198-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings