A Clinical Trial of Mass Balance of [14C] TQ05105 in Healthy Chinese Subjects

CTTQ

Status and phase: Completed; Phase 1

Conditions: Mass Balance of [14C] TQ05105 in Healthy Chinese Subjects

Treatments: Drug: TQ05105

Study type: Interventional

Funder types: Industry

Identifiers

NCT07293390

TQ05105-I-05

Details and patient eligibility

About

To analyze radioactivity excretion and pharmacokinetics in healthy subjects after a single oral dose of [¹⁴C]TQ05105, identifying excretion routes, major metabolites, and biotransformation pathways. Secondary: To determine pharmacokinetics of TQ05105 and metabolites (e.g., TQ12550) via Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) and assess treatment safety.

Enrollment: 6 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult male;
• Age: 18-45 years (inclusive);
• Body weight: Body mass index (BMI) between 19-26 kg/m² (inclusive), with a minimum body weight of 50 kg;
• Voluntarily signs the informed consent form;
• The subject is able to communicate well with the investigator and able to complete the trial in accordance with the protocol requirements.

Exclusion criteria

• Abnormalities with clinical significance detected in comprehensive physical examination, routine laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis, fecal routine), thyroid function, 12-lead electrocardiogram, chest CT, abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidneys), etc.;
• Abnormal vital signs that remain abnormal upon retesting;
• Abnormalities with clinical significance in ophthalmic examinations (slit-lamp, intraocular pressure, and fundus photography);
• Positive results for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody IgG (Anti-HCV IgG), human immunodeficiency virus antibody (HIV-Ag/Ab), or syphilis antibody;
• Positive nucleic acid test result for Coronavirus Disease 2019 (COVID-19);
• Use of any drugs known to inhibit or induce hepatic drug-metabolizing enzymes within 30 days prior to screening (see Appendix 1 for details);
• Use of any prescription drugs, over-the-counter medications, Chinese herbal health products, or dietary supplements (e.g., vitamins, calcium supplements) within 14 days prior to screening;
• History or presence of clinically significant diseases affecting the musculoskeletal, neuropsychiatric, endocrine, circulatory, respiratory, digestive, urinary, or reproductive systems, as judged by the investigator;
• Any medical condition that increases the risk of elevated blood glucose, such as a history of primary diabetes, steroid-induced diabetes, other secondary diabetes, acute or chronic pancreatitis, deemed clinically significant by the investigator;
• History of organic heart disease, heart failure, myocardial infarction, angina, unexplained arrhythmia, torsades de pointes, ventricular tachycardia, atrioventricular block, or long QT syndrome (or related symptoms/family history), deemed clinically significant by the investigator;
• History of interstitial lung disease, severely impaired lung function, severe pulmonary fibrosis, radiation pneumonitis, drug-induced lung disease, or evidence of active pulmonary inflammation on screening chest CT, deemed clinically significant by the investigator;
• Major surgery within 6 months prior to screening or incomplete wound healing; major surgery includes procedures with significant bleeding risk, prolonged general anesthesia, open biopsy, major traumatic injury, or surgery affecting drug absorption, distribution, metabolism, or excretion; or planned surgery during the study;
• History of drug, environmental, or food allergies, allergic constitution, or potential allergy to the investigational drug or its excipients, as judged by the investigator;
• Hemorrhoids or perianal diseases with regular/active bleeding, irritable bowel syndrome, or inflammatory bowel disease;
• Factors affecting oral administration or drug absorption (e.g., swallowing difficulties, gastrointestinal resection, ulcerative colitis, symptomatic/inflammatory bowel disease, intestinal obstruction, etc.);
• Habitual constipation or diarrhea;
• Lactose intolerance (history of diarrhea after consuming milk);
• Alcohol abuse or regular alcohol consumption within 6 months prior to screening (>14 units per week; 1 unit = 360 mL beer, 45 mL 40% spirits, or 150 mL wine); inability to abstain during the trial, or positive alcohol breath test (>0 mg/100 mL) at screening;
• Smoking >5 cigarettes daily within 3 months prior to screening or habitual use of nicotine products, and inability to abstain during the trial;
• Drug abuse or use of soft drugs (e.g., marijuana) within 3 months prior to screening, or hard drugs (e.g., cocaine, amphetamines, phencyclidine) within 1 year prior to screening; or positive urine drug screen at screening;
• Habitual consumption of grapefruit juice or excessive tea, coffee, and/or caffeine-containing beverages, and inability to abstain during the trial;
• Occupation involving long-term exposure to radiation conditions; or significant radiation exposure within 1 year prior to the trial (≥2 chest/abdominal CT scans or ≥3 other X-ray examinations); or prior participation in radioactive drug-labeled trials;
• History of needle or blood phobia, difficulty with blood collection, or inability to tolerate venipuncture;
• Participation in other clinical trials involving investigational drugs or devices within 3 months prior to or during screening, or planned participation during this study; or non-personal participation in clinical trials;
• Vaccination within 1 month prior to screening or planned vaccination during the trial;
• Plans for reproduction or sperm donation during the trial or within 1 year after completion, or unwillingness to use strict contraception during and within 1 year after the trial (see Appendix 3 for details);
• Blood loss or donation ≥400 mL within 3 months prior to screening, or blood transfusion within 1 month prior to screening;
• Other reasons deemed by the investigator to make the subject unsuitable for participation, or voluntary withdrawal by the subject.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 1 patient group

TQ05105

Experimental group

Description:

Take the \[14C\]TQ05105 suspension under fasting conditions, ensuring the entire dose is administered within 5 minutes. The total water volume used for drug preparation and administration is approximately 240 mL.

Treatment:

Drug: TQ05105