Renal anemia
Conditions
Interventions
Sponsors
Beijing GoBroad Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Subjects must have fully known and understood the study, its contents, process and possible adverse events related to the study drug before the study, and voluntarily signed a written informed consent form; 2.Chinese adult male subjects aged 18~50 years (inclusive); 3.The weight of the subject at screening was not less than 50 kg, and the body mass index [BMI= weight (kg)/height2 (m2)] was within the range of 19.0~26.0 kg/m2 (including boundary value); 4.Subjects had no sperm donation plan for 6 months after dosing, subjects and their partners had no pregnancy plan during the study and for 6 months after dosing and voluntarily took effective contraceptive measures (contraceptive pills were prohibited during the subject's study) to avoid pregnancy of the subject's partner.
Exclusion criteria
Exclusion criteria: 1. The investigator determines that there are other diseases or medical histories that are clinically significant or may prevent the subject from complying with the study protocol and completing the study, including but not limited to central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, mental system, endocrine metabolism system and other abnormalities; 2. Those with abnormal vital signs, physical examination, routine laboratory examination (blood routine, urine routine, stool routine + occult blood, blood biochemistry, coagulation function), 12-lead ECG, chest X-ray (positive position), abdominal B-ultrasound at screening or baseline and judged to be clinically significant by the investigator; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal (ULN) at screening/baseline; 3.12-lead ECG with the following results at screening or baseline: QTcF= 450 ms; Or abnormal ECG with clinical significance; 4. The results of hepatitis B surface antigen quantitative assay, hepatitis C antibody assay, treponema pallidum antibody assay and human immunodeficiency virus antigen antibody assay were positive. 5. Dyspepsia, esophageal reflux, or peptic ulcer disease within 3 months prior to dosing, or any surgical procedure that may affect drug absorption (e.g., cholecystectomy, except for appendicitis); Or those who plan to undergo surgery during the trial; 6. Hemorrhoids with hematochezia or perianal disease with regular/ongoing hematochezia; Or severe nausea or vomiting within the week prior to screening; Or habitual constipation or diarrhoea; Or positive stool occult blood test; 7. Use any prescription drug, over-the-counter drug, Chinese herbal medicine, food supplement (including vitamins, health food, etc.) or other non-drug treatment factors affecting drug absorption, distribution, metabolism and excretion within 14 days before administration; 8. A clinically significant history of drug allergy or allergic disease (e.g., asthma, urticaria, eczematous dermatitis, etc.), or a possible or definite allergy to the investigational drug (including similar drugs) and any of its excipients as judged by the investigator; 9. Received any other clinical trial drug or participated in any interventional clinical study within 3 months prior to screening; Blood donation or blood loss of 400 ml or more within three months before administration, or blood transfusion or blood product use within four weeks before administration; 11. Difficult or intolerant to venous puncture; 12.Employees who are exposed to radioactive conditions for a long time, or have significant radioactive exposure within one year prior to screening (=2 chest/abdomen CTs, or =3 other x-ray examinations), or have participated in radiopharmaceutical labeling tests within one year prior to screening; 13. a history of drug or substance abuse, or a positive urine drug abuse screening (morphine, methamphetamine, ketamine, tetrahydrocannabinoic acid, methylenedioxymethamphetamine); 14.Average =14 units of alcohol (360 ml of beer or 45 mL of liquor or 150 ml of wine in one unit of ˜) per week in the three months prior to screening, or positive breath test results of alcohol; 15. >5 cigarettes per day (or equivalent nicotine products) in the three months before screening, or no tobacco products can be stopped during the test; 16. Habitual consumption of grapefruit juice or excessive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery and cumulative recovery of total radioactivity in excreta (urine and feces);Percentage of unchanged drug and metabolite in total radioactivity exposure of whole blood; Percentage of unchanged drug, metabolite (if applicable) in urine and feces in the dose; Identification of major metabolites in whole blood, urine and feces.;Pharmacokinetic parameters of total radioactivity in whole blood and plasma (if applicable); Ratio of total radioactivity concentration in whole blood and plasma, etc.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of dedustat and its metabolites (if applicable) in whole blood and plasma (if necessary);Safety evaluation: Vital signs, physical examination, laboratory tests, 12-lead ECG, adverse events, etc.; | — |
Countries
China
Contacts
Public ContactHou Fang
Beijing GoBroad Hospital
Outcome results
None listed