The Absorption, Metabolism and Excretion of [14C] HQP1351 in Humans
Study Details
Study Description
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 clinical development, human mass balance data are required to elucidate the absorption, metabolism, and excretion of HQP1351.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: [14C] HQP1351 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. |
Drug: [14C] HQP1351
Orally, single dose of 30mg
|
Outcome Measures
Primary Outcome Measures
- Radioactivity concentration of each blood and plasma sample [Day 1- Day 15]
Use liquid scintillation counter to evaluate Radioactivity concentration of each blood and plasma sample
- Radioactivity concentration of each urine samples [Day 1- Day 15]
Use liquid scintillation counter to evaluate Radioactivity concentration of each urine sample
- Radioactivity concentration of each feces samples [Day 1- Day 15]
Use liquid scintillation counter to evaluate Radioactivity concentration of each feces sample
- Total recovery of radioactivity in urine and feces [Day 1- Day 15]
Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample
Secondary Outcome Measures
- Plasma drug concentrations [Day 1- Day 15]
To determine the plasma concentrations of HQP1351 with validated LC-MS/MS method for obtaining its pharmacokinetics parameters
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Day 1- Day 15]
According to CTCAE v5.0, the number and frequency of adverse events after a single dose of test drug were assessed.
Eligibility Criteria
Criteria
Inclusion Criteria:
A subject will be eligible for study participation if he meets the following criteria:
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Healthy male volunteers between the ages of 18 to 50 years old, inclusive;
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Body weight >=50 kg, Body mass index (body weight(kg)/hight2(m2)) between 19 and 26 kg/m2 (inclusive);
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Normal physical findings, clinical laboratory values, vital signs and 12-lead ECG, or any abnormality that is non-clinically significant;
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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.
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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:
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History of or current clinically significant cardio, pulmonary, endocrine, metabolism, renal, hepatic, gastrointestinal, dermatology, infection, hematology, neurological, mental disease or disorder;
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Positive test for HBsAg, HBeAg, anti-HCV, anti-HIV or syphilis antibody;
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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;
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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)
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The following abnormal clinical laboratory values
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HGB < LLN or HGB>ULN, and is judged as clinically significant by the investigator；
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Abnormal ALB, TP, CRE, ALT, AST, BIL, BUN, GLU value, and is judged as clinically significant by the investigator;
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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;
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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;
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History of or current swallowing disorder, active gastrointestinal diseases, or other diseases that significantly affect absorption, distribution, metabolism and excretion of drugs;
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Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease or history of gastrointestinal surgery and cholecystectomy;
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Hemorrhoids or perianal disease with regular/perianal bleeding;
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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);
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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;
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Vaccination was administered within 6 months prior to screening or during screening;
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History of drug or alcohol abuse;
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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;
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Subject with mentally ill and could not understand the property, scope and possible consequences of the study;
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subject in prison or whose freedom is restricted by administrative or legal issues;
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Failure to comply with clinical study protocols, such as non-cooperation, follow-up visit and completion of entire study;
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Abnormal coagulation function or known severe bleeding tendency;
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Subjects who have participated in radiolabeled clinical study prior to drug administration;
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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).
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Investigators think that subjects are not suitable to participate in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital with Nanjing Medical University | Nanjing | China |
Sponsors and Collaborators
- Ascentage Pharma Group Inc.
- HealthQuest Pharma Inc.
Investigators
- Principal Investigator: Feng Shao, Doctor, The First Affiliated Hospital with Nanjing Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HQP1351XC105