Pharmacokinetics, Mass Balance, and Metabolism of [14C]HSK31679 in Healthy Adult Male Volunteers.
- Conditions
- Healthy
- Registration Number
- NCT06258746
- Lead Sponsor
- Xizang Haisco Pharmaceutical Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria:<br><br> 1. Healthy male subjects, Age: 18~45 years old (inclusive);<br><br> 2. A total body weight =50 kg and BMI of 19 to 26 kg/m^2(inclusive);<br><br> 3. Subjects who are willing to sign an informed consent form, able to communicate with<br> the investigator and to complete all trial procedures as per the protocol.<br><br>Exclusion Criteria:<br><br> 1. Clinically significant abnormal results for comprehensive physical examination,<br> vital signs, routine laboratory tests [blood routine, blood biochemistry,<br> coagulation routine, urine routine, Fecal analysis, thyroid function and antibodies,<br> visual acuity and ophthalmic examination (slit lamp, introcular pressure, and<br> fundoscopy), 12-lead electrocardiogram (ECG), chest X-ray (anteriorposterior), and<br> abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, and kidney);<br><br> 2. Positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or<br> Treponema pallidum antibodies;<br><br> 3. Use of any Western medicine or Chinese patent medicine (including prescription drug,<br> over-the-counter drug, health care product, or live attenuated influenza vaccine)<br> within 14 days prior to screening;<br><br> 4. Participation in any clinical trial and interference with other investigational drug<br> or medical device within 3 month prior to screening;<br><br> 5. Any clinical serious illness that has previously or currently affected the<br> cardiovascular system, digestive system, respiratory system, endocrine system,<br> nervous system, hematology, immunology, skin, tumors, psychiatry, and metabolic<br> abnormalities, or any other disease or physiological condition that can interfere<br> with trial results;<br><br> 6. Have undergone major surgery within 6 months prior to screening or with incomplete<br> healing of the surgical incision; major surgery includes, but is not limited to, any<br> surgery with significant risk of bleeding, prolonged general anesthesia, or<br> incisional biopsy or obvious traumatic injury (excluding cured appendicitis surgery<br> or rectal prolapse surgery);<br><br> 7. Severe allergic constitution, including known allergy to THR- ß receptor agonists or<br> any excipient of this investigational product, two or more drugs and food<br> components, or with special dietary requirements and thus unable to follow a<br> standardized diet;<br><br> 8. Concomitant hemorrhoids or perianal diseases with regular/ongoing rectal bleeding;<br><br> 9. Subjects who had Irregular bowel movements or diarrhea, irritable bowel syndrome,<br> inflammatory bowel disease;<br><br> 10. Excessive drinking or frequent drinking within the first 6 months of the screening<br> period, i.e. drinking more than 14 units of alcohol per week (1 unit=360 mL of beer<br> or 45 mL of 40% alcohol or 150 mL of wine); Positive alcohol breath test during the<br> screening period;<br><br> 11. Subjects who smoked more than 5 cigarettes a day or habitually used<br> nicotine-containing products in the 3 months before the screening period and could<br> not quit during the test period;<br><br> 12. Drug abuse or dependence, urine screening positive for drug abuse;<br><br> 13. Habitually drinking grapefruit juice or excessive (more than 8 cups a day, 1 cup<br> =250mL) tea, grapefruit, coffee, drinks containing caffeine or grapefruit, and could<br> not quit during the test period;<br><br> 14. Subjects who need to work in a condition with long-term radioactive exposure; or who<br> have experienced significant radioactive exposure (=2 chest/abdominal CT scans, or<br> =3 other types of X-rays) within 1 year or participated in the radiopharma labeling<br> test prior to the test;<br><br> 15. Subjects who have a birth plan during the study period and within 1 year after<br> completion of the study, or who don't agree that the subject and his or her spouse<br> should take strict contraceptive measures (condoms, contraceptive sponges,<br> contraceptive gels, contraceptive membranes, intrauterine devices, oral or<br> injectable contraceptives, subcutaneous implants, etc.) during the study period and<br> within 1 year after completion of the study;<br><br> 16. Subjects who have experienced blood loss or donated 400 mL of blood within the first<br> 3 months of the screening period, or have received blood transfusions within 1<br> month;<br><br> 17. Volunteers judged by the investigator to be unsuitable for participating in this<br> trial for any reason.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mass balance
- Secondary Outcome Measures
Name Time Method AUC(0-t);AUC(0-8);Cmax