Clinical trial · Interventional
The Absorption, Metabolism and Excretion of [14C] HQP1351 in Humans
A Single-center, Open-label, Single-dose Phase I Study to Investigate the Absorption, Metabolism and Excretion of [14C] HQP1351 After a Single Oral 30mg (100µCi) Dose in Healthy Chinese Male Subjects
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia (CML) | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [14C] HQP1351 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [14C] HQP1351
- description
- To investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose (30mg, 100µCi) of \[14C\] HQP1351 to healthy Chinese male subjects.
- interventionNames
- Drug: [14C] HQP1351
Primary outcomes (4)
- measure
- Radioactivity concentration of each blood and plasma sample
- timeFrame
- Day 1- Day 15
- description
- Use liquid scintillation counter to evaluate Radioactivity concentration of each blood and plasma sample
- measure
- Radioactivity concentration of each urine samples
- timeFrame
- Day 1- Day 15
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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\<90 mmHg, or DBP \<=55 mmHg), Pulse rate\<55 bpm or \>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 \< LLN or 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.
References
Publications (0)
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