Status:
COMPLETED
The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers
Lead Sponsor:
Nanjing Sanhome Pharmaceutical, Co., Ltd.
Conditions:
Healthy Male Volunteers
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of \[14C\] SH-1028 in healthy Chinese male subjects. The study will be conducted ...
Detailed Description
Subjects who had signed informed consent and meet inclusion criteria and no exclusion criteria are admitted to Phase I Clinical Unit two days prior to dosing (D-2). On the morning of Day 1 before dosi...
Eligibility Criteria
Inclusion
- Healthy male volunteers between the age of 18 to 50 years old；
- Body weight \>=50 kg, Body mass index between 19 and 26 kg/m2 (including 19 and 26 kg/m2);
- Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant;
- Male subjects of reproductive potential with partners will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 6 months after discontinuing treatment with the investigational product.;
- Signing the informed consent forms by oneself;
- Be able to communicate well with the researcher and be able to complete the trial in accordance with the program.
Exclusion
- History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder;
- Positive test for HBs-Ag, HCV-Ab, HIV-Ab, or syphilis antibody;
- Long-QT syndrome or family history of it, or QTcF interval \> 450 mses;
- Allergies, have allergies to drugs or foods; or have known allergies to the components of the drug;
- Those who smoked daily \>5 sticks of cigarette 3 months prior to first dose or cannot give up smoking during study；
- The weekly alcohol consumption was higher than 14 units of alcohol (1 unit=10ml or 8g absolute alcohol. 25 ml 40% liquor, 330ml 5% beers, 175ml 12% grape wine are equal to 1.0, 1.5 and 2.0 units of alcohol respectively) 3 months prior to screening period, or positive test for the alcohol breath test results during screening period；
- Those have history of drug abuse or taking soft drug (i.e., marihuana); or the results of urine test in drugs were positive;
- Participated in other clinical trials within 3 months before screening;
- Received any drug within 14 days before taking the investigational drug;
- Received any drugs that inhibit or induce the CYP450 enzyme (i.e., inducers- barbiturates, tegretol, phenytoin, rifampicin, hexadecadrol, rifabutin, rifapentini; inhibitors- SSRI-antidepressant, cimetidine, diltiazem, macrolides, verapamil, imidazoles- antifungal drugs) 30 days prior to screening period；
- History of syncope / needle syncope and intolerable intravenous indwelling needle;
- Those who have undergone major surgery within the first 6 months of the screening period;
- Those who have habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease；
- Hemorrhoids or perianal disease with regular/perianal bleeding;
- Significant radiation exposure within one year prior to drug administration (more than one exposure from chest X-ray, CT scan, or barium meal examination and radiation-related occupations);
- Those who cannot complete this study because of other reasons, or any factors judged by investigator that the participants cannot meet.
Key Trial Info
Start Date :
May 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04810533
Start Date
May 13 2020
End Date
March 5 2021
Last Update
March 23 2021
Active Locations (1)
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1
Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine
Nanjing, Jiangsu, China, 210029