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Material Balance Study of TQ-B3525

Clinical Trial on Absorption, Metabolism and Excretion of [14C] TQ-B3525 in Chinese Adult Male Healthy Subjects - Research on Material Balance and Biotransformation of [14C] TQ-B3525

NCT05675202•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

A clinical study to investigate the absorption, metabolism and excretion of \[14C\] TQ-B3525 in Chinese adult male healthy subjects, aiming to quantitatively analyze the total radioactivity in the excreta of male healthy subjects after oral administration of \[14C\] TQ-B3525, obtain the data of human radioactive excretion rate and main drainage routes, investigate the distribution in whole blood and plasma, the distribution in plasma and the pharmacokinetics of total radioactivity in plasma, and identify the main metabolites, To determine the main biotransformation pathway and obtain the pharmacokinetic parameters of TQ-B3525 and its metabolites in plasma.

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy adult male;
•Age: 18-45 years old (including boundary value);
•Body weight: Body mass index (BMI) is between 19 and 26 kg/m2 (including the boundary value), and the weight of the subject is not less than 50 kg;
•Sign the informed consent form voluntarily;
•The subjects were able to communicate well with the researchers and complete the trial according to the protocol.

Exclusion Criteria

•Those with abnormal and clinically significant results from comprehensive physical examination, vital signs, routine laboratory examination (blood routine examination, blood biochemistry, blood coagulation function, urine routine examination, stool routine examination, glycosylated hemoglobin, lipase, amylase), thyroid function, 12 lead ECG, chest CT, abdominal B ultrasound (liver, gallbladder, pancreas, spleen and kidney), etc;
•Abnormal ophthalmic examination (slit lamp, intraocular pressure and fundus photography) with clinical significance;
•Hepatitis B surface antigen or E antigen, anti HCV IgG, HIV Ag/Ab and Treponema pallidum antibody positive;
•Cytomegalovirus (CMV) antibody positive;
•Novel coronavirus nucleic acid positive;
•Any drugs that inhibit or induce liver drug metabolizing enzymes were used within 30 days before the screening period (see Appendix 1 for details);
•Have used any prescription drugs, over-the-counter drugs, Chinese herbal medicine or food supplements, such as vitamins and calcium supplements, within 14 days before the screening period;
•Any serious clinical disease history or any disease or circumstance that the researcher thinks may affect the test results, including but not limited to the history of circulatory system, respiratory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases;
•People with any disease that increases the risk of elevated blood sugar, such as those with a history of primary diabetes, steroid induced diabetes or other secondary diabetes, and those with acute or chronic pancreatitis;
•People who have a history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, history of torsade, ventricular tachycardia, atrioventricular block, history of prolonged QT syndrome, or symptoms of prolonged QT syndrome and family history (certified by genetics or sudden death of a close relative due to cardiac causes when young);
+17 more criteria

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

January 1, 2023

Primary Completion Date

August 1, 2023

Completion Date

December 1, 2023

Last Updated

January 12, 2023

Enrollment

ESTIMATED participants

Conditions

Chronic Kidney DiseasesMagnetic Resonance Imaging

Interventions

TQ-B3525

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Material Balance Study of TQ-B3525

Inclusion Criteria

Exclusion Criteria

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