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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Nanjing, China
- The First Affiliated Hospital with Nanjing Medical University
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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.
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Orally, single dose of 30mg
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radioactivity concentration of each blood and plasma sample
Time Frame: Day 1- Day 15
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Use liquid scintillation counter to evaluate Radioactivity concentration of each blood and plasma sample
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Day 1- Day 15
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Radioactivity concentration of each urine samples
Time Frame: Day 1- Day 15
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Use liquid scintillation counter to evaluate Radioactivity concentration of each urine sample
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Day 1- Day 15
|
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Radioactivity concentration of each feces samples
Time Frame: Day 1- Day 15
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Use liquid scintillation counter to evaluate Radioactivity concentration of each feces sample
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Day 1- Day 15
|
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Total recovery of radioactivity in urine and feces
Time Frame: Day 1- Day 15
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Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample
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Day 1- Day 15
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Plasma drug concentrations
Time Frame: Day 1- Day 15
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To determine the plasma concentrations of HQP1351 with validated LC-MS/MS method for obtaining its pharmacokinetics parameters
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Day 1- Day 15
|
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Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: Day 1- Day 15
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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.
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Day 1- Day 15
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Feng Shao, doctor, The First Affiliated Hospital with Nanjing Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- HQP1351XC105
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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