Status:
COMPLETED
The Absorption, Metabolism and Excretion of [14C] HQP1351 in Humans
Lead Sponsor:
Ascentage Pharma Group Inc.
Collaborating Sponsors:
HealthQuest Pharma Inc.
Conditions:
Chronic Myeloid Leukemia (CML)
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- A subject will be eligible for study participation if he meets the following criteria:
- Healthy male volunteers between the ages of 18 to 50 years old, inclusive;
- Body weight \>=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2 (inclusive);
- 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 1 year after discontinuing treatment with the investigational product.
- Must understand, and voluntarily sign the informed consent, comply with the requirements of the study.
Exclusion
- A subject will not be eligible for study participation if he meets any of the exclusion criteria:
- History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder;
- Positive test for HBsAg, HBeAg, anti-HCV, anti-HIV or syphilis antibody;
- Abnormality in blood pressure, including hypertensive BP (SBP\>=140 mmHg, or DBP \>=90 mmHg), or hypotensive BP (SBP\<90 mmHg, or DBP \<=55 mmHg), Pulse rate\<55 bpm or \>100 bpm;
- 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)
- The following abnormal clinical laboratory values
- HGB \< LLN or HGB\>ULN, and is judged as clinically significant by the investigator；
- Abnormal ALB, TP, CRE, ALT, AST, BIL, BUN, GLU value, and is judged as clinically significant by the investigator;
- 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;
- 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;
- History of or current swallowing disorder, active gastrointestinal diseases, or other diseases that significantly affect absorption, distribution, metabolism and excretion of drugs;
- Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease or history of gastrointestinal surgery and cholecystectomy;
- Hemorrhoids or perianal disease with regular/perianal bleeding;
- 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);
- 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;
- Vaccination was administered within 6 months prior to screening or during screening;
- History of drug or alcohol abuse;
- 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;
- Subject with mentally ill and could not understand the property, scope and possible consequences of the study;
- subject in prison or whose freedom is restricted by administrative or legal issues;
- Failure to comply with clinical study protocols, such as non-cooperation, follow-up visit and completion of entire study;
- Abnormal coagulation function or known severe bleeding tendency;
- Subjects who have participated in radiolabeled clinical study prior to drug administration;
- 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).
- Investigators think that subjects are not suitable to participate in the study.
Key Trial Info
Start Date :
November 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04126707
Start Date
November 19 2019
End Date
January 13 2020
Last Update
September 8 2021
Active Locations (1)
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1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China