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| Name | Class |
|---|---|
| HealthQuest Pharma Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C] HQP1351 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] HQP1351 | Drug | Orally, single dose of 30mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radioactivity concentration of each blood and plasma sample | Use liquid scintillation counter to evaluate Radioactivity concentration of each blood and plasma sample | Day 1- Day 15 |
| Radioactivity concentration of each urine samples | Use liquid scintillation counter to evaluate Radioactivity concentration of each urine sample | Day 1- Day 15 |
| Radioactivity concentration of each feces samples | Use liquid scintillation counter to evaluate Radioactivity concentration of each feces sample | Day 1- Day 15 |
| Total recovery of radioactivity in urine and feces | Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample | Day 1- Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma drug concentrations | To determine the plasma concentrations of HQP1351 with validated LC-MS/MS method for obtaining its pharmacokinetics parameters | Day 1- Day 15 |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
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Inclusion Criteria:
A subject will be eligible for study participation if he meets the following criteria:
Exclusion Criteria:
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
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.
Male
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| Name | Affiliation | Role |
|---|---|---|
| Feng Shao, Doctor | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Nanjing | China |
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| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C579813 | olverembatinib |
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According to CTCAE v5.0, the number and frequency of adverse events after a single dose of test drug were assessed. |
| Day 1- Day 15 |
| D009196 |
| Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |