the absorption, metabolism and excretion of [14c] hqp1351 in humans

Conditions: Chronic Myeloid Leukemia (CML)

Summary: the objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 30mg (100µci) dose of \[14c\] hqp1351 given as a suspension. for further clinical development, human mass balance data are required to elucidate the absorption, metabolism, and excretion of hqp1351.


Eligibility criteria:
inclusion criteria: a subject will be eligible for study participation if he meets the following criteria: 1. healthy male volunteers between the ages of 18 to 50 years old, inclusive; 2. body weight \>=50 kg, body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2 (inclusive); 3. normal physical findings, clinical laboratory values, vital signs and 12-lead ecg, or any abnormality that is non-clinically significant; 4. 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 1 year after discontinuing treatment with the investigational product. 5. must understand, and voluntarily sign the informed consent, comply with the requirements of the study. exclusion criteria: a subject will not be eligible for study participation if he meets any of the exclusion criteria: 1. history of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder; 2. positive test for hbsag, hbeag, anti-hcv, anti-hiv or syphilis antibody; 3. abnormality in blood pressure, including hypertensive bp (sbp\>=140 mmhg, or dbp \>=90 mmhg), or hypotensive bp (sbp\ 100 bpm; 4. long-qt syndrome or family history of it, or qtcb interval \> 450 ms; intraventricular blocks or left/right bundle branch block or qrs\>120ms; frequent ventricular ectopic beats (any 10s ecg ventricular premature beat \>= 1 in screening period); or abnormal resting heart rate (\> 100 bpm) 5. the following abnormal clinical laboratory values 1. hgb \ uln, and is judged as clinically significant by the investigator； 2. abnormal alb, tp, cre, alt, ast, bil, bun, glu value, and is judged as clinically significant by the investigator; 6. received any drug within 14 days before taking the investigational drug, including any prescription drug, otc drug, herbal drug or health care product with medicinal effect; 7. received any other investigating products or participated in any clinical trails three month before screening or within 10 t1/2 after receiving other investigating products; 8. history of or current swallowing disorder, active gastrointestinal diseases, or other diseases that significantly affect absorption, distribution, metabolism and excretion of drugs; 9. chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease or history of gastrointestinal surgery and cholecystectomy; 10. hemorrhoids or perianal disease with regular/perianal bleeding; 11. allergies, have allergies to two or more drugs or foods; or have known allergies to the components of the drug (microcrystalline cellulose, stearic acid, croscarmellose sodium); 12. have donated 400ml or more of blood or plasma 3 months prior to the study drug administration, or more than 50ml within 2 weeks prior to administration; 13. vaccination was administered within 6 months prior to screening or during screening; 14. history of drug or alcohol abuse; 15. smoking (\> 10 cigarette / day), drinking (\> 15 g, pure alcohol / day, equivalent to 450 ml beer, 150 ml wine or 50 ml low-alcohol liquor), or abusing drugs within last 3 months; 16. subject with mentally ill and could not understand the property, scope and possible consequences of the study; 17. subject in prison or whose freedom is restricted by administrative or legal issues; 18. failure to comply with clinical study protocols, such as non-cooperation, follow-up visit and completion of entire study; 19. abnormal coagulation function or known severe bleeding tendency; 20. subjects who have participated in radiolabeled clinical study prior to drug administration; 21. 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). 22. investigators think that subjects are not suitable to participate in the study.

Keywords: chronic myeloid leukemia hqp1351