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

NCT06137573 | Completed Phase 1 FDA Drug

• 1 other identifier: TNP-2198-05
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (4)

• Cumulative excretion rate of total radioactivity in excreta (urine and feces)

  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

  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

  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

  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

Study Arms (1)

[14C]TNP-2198

EXPERIMENTAL

Participants will take a single dose of 600mg 150μCi of \[14C\]TNP-2198.

Drug: [14C]TNP-2198

Interventions

[14C]TNP-2198 DRUG

600mg suspension containing 150μCi of \[14C\] TNP-2198

Also known as: Rifasutenizol

[14C]TNP-2198

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• TenNor Therapeutics (Suzhou) Limited: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 18, 2023
• Study Start: July 12, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)