Actively Recruiting
A Study To Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2024-09-04
10
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, a single dose of \[14C\] radiolabelled HDM1002 will be administered orally. The main purpose of this study is to find out how much of HDM1002 and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral \[14C\] HDM002.
CONDITIONS
Official Title
A Study To Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, healthy adult
- Age between 18 and 45 years old (inclusive)
- Body mass index (BMI) between 19.0 and 32.0 kg/m2 (inclusive)
- Body weight of at least 50.0 kg
You will not qualify if you...
- Clinically significant diseases at screening
- History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2)
- Calcitonin level 65 35 ng/L during screening
- History of chronic pancreatitis or acute pancreatitis within 3 months prior to screening
- History of acute cholecystitis attack within 3 months prior to screening
- Conditions affecting swallowing, gastric emptying, or nutrient absorption (e.g., bariatric surgery, gastrectomy, irritable bowel syndrome, dyspepsia)
- Habitual constipation or diarrhea, hemorrhoids with perianal disease, irritable bowel syndrome, inflammatory bowel disease
- Use of prescription, over-the-counter medication, Chinese herbal medicine, or food supplements within 14 days or 5 half-lives before screening
- Abnormal clinically significant findings in physical examination
- History of drug abuse or positive urine drug test at screening
- Positive tests for hepatitis B surface or E antigen, hepatitis C antibody, HIV antigen/antibody, or Treponema pallidum antibody at screening
- Long-term occupational exposure to radioactivity or significant radiation exposure (65 2 CT scans or 65 3 other X-rays) within 1 year prior to the trial
- Participation in radio-label trials previously
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
Research Team
L
Liyan Miao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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