Material Balance Study of TQ-B3525

NCT05675202 | Unknown Phase 1

• 1 other identifier: TQ-B3525-I-04
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Diseases; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (3)

• Peak concentration (Cmax)

  Maximum plasma drug concentration

  Before administration, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration

• Area under drug time curve (AUC 0-t)

  Area under the plasma concentration time curve from time 0 to last time of quantifiable concentration

  Before administration, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration

• Area under drug time curve (AUC 0-last)

  Area under the plasma concentration-time curve from time 0 extrapolated to infinite time

  Before administration, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, 336 hours after administration

Secondary Outcomes (1)

• Incidence rate of adverse events

  Before the first administration until it returns to normal or the level considered acceptable by the investigator

Study Arms (1)

TQ-B3525 tablet

EXPERIMENTAL

100 µ Ci \[14C\] TQ-B3525, 20mg, once in total

Drug: TQ-B3525

Interventions

TQ-B3525 DRUG

TQ-B3525 is a new PI3K α/δ Kinase inhibitor

TQ-B3525 tablet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Healthy adult male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• History of interstitial lung disease, severe impairment of lung function, severe pulmonary fibrosis, radiation pneumonitis, drug-induced lung disease, and chest CT findings during screening period suggest evidence of active pulmonary inflammation;
• Major surgery or incomplete healing of surgical incision within 6 months before the screening period; Major surgery includes, but is not limited to, any surgery with significant bleeding risk, extended general anesthesia period, or open biopsy or obvious traumatic injury;
• Allergic constitution, such as known history of allergy to two or more substances; Or the investigator may be allergic to the test drug or its excipients;
• Hemorrhoids or perianal diseases, irritable bowel syndrome, inflammatory bowel disease with regular/ongoing blood in the stool;
• People with multiple factors affecting oral administration and drug absorption (such as inability to swallow, gastrointestinal resection, ulcerative colitis, symptomatic/inflammatory bowel disease, intestinal obstruction, etc.); habits and customs:

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

TQ-B3525

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 9, 2023
• Study Start: January 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 12, 2023

Record last verified: 2022-08

Locations

CN (1)