Recruiting NCT06576401
A Study To Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [14C] HDM1002.
- Who it may be relevant to
- Registry conditions: Healthy Adult Subject. Basic parameters: 18 years — 45 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase1 Study to Characterize Mass Balance Of [14C] HDM1002 in Chinese Healthy Subjects
Overview
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.
Interventions
- Drug [14C] HDM1002
Administered orally
Primary outcome measures
- Total recovery of HDM1002 radioactivity in urine and feces, following oral administration of [14C] HDM1002 [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Metabolite profiling/identification in plasma, urine, and feces [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Plasma and whole blood AUC[0-t] of radioactivity [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Plasma and whole blood AUC[0-∞] of radioactivity [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Plasma and whole blood Cmax of radioactivity [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Plasma and whole blood Tmax of radioactivity [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Plasma and whole blood t1/2 of radioactivity [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Plasma and whole blood CL/F of radioactivity [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Plasma and whole blood Vz/F of radioactivity [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Percentage of plasma HDM1002 and metabolites in total plasma radioactivity [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
Secondary outcome measures (8)
- Plasma AUC[0-t] of HDM1002 and metabolites [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Plasma AUC[0-∞] of HDM1002 and metabolites [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Plasma Cmax of HDM1002 and metabolites [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Plasma Tmax of HDM1002 and metabolites [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Plasma t1/2 of HDM1002 and metabolites [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Plasma CL/F of HDM1002 and metabolites [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Plasma Vz/F of HDM1002 and metabolites [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
- Adverse events (AEs) [Time frame: Predose up to Day 11 after administration of [14C] HDM1002]
Eligibility criteria
Inclusion criteria
- Male, healthy adult;
- Age of 18 to 45 years old (both inclusive);
- Body mass index (BMI) between 19.0- 32.0 kg/m2 (both inclusive) and body weight no less than 50.0 kg.
Exclusion criteria
- Clinically significant diseases at the time of screening;
- History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin ≥ 35 ng/L during the screening period;
- History of chronic pancreatitis or acute pancreatitis within 3 months prior to screening;
- History of acute cholecystitis attack within 3 months prior to screening;
- Participant judged by investigator has dysphagia, diseases or conditions that affect gastric emptying or affect the absorption of nutrients in the gastrointestinal tract, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.;
- Any of the following: habitual constipation or diarrhea, hemorrhoids or accompanied by perianal disease, irritable bowel syndrome, inflammatory bowel disease, etc;
- Use of any prescription medication, over-the-counter medication, Chinese herbal medicine or food supplement within 14 days or 5 half-lives (whichever is longer) prior to the screening period;
- Patients with any abnormal and clinically significant examinations in given comprehensive physical examination;
- History of drug abuse (e.g., morphine, ketamine, tetrahydrocannabinolic acid, metham phetamine, methylenedioxyamphetamine, cocaine) or positive urine drug test during the screening period;
- Positive for hepatitis B surface antigen or E antigen, hepatitis C virus antibody IgG (Anti-HCV IgG), human immunodeficiency virus antigen/antibody combination test (HIV-Ag/Ab) and Treponema pallidum antibody during the screening period.
- Engaged in working conditions requiring long-term exposure to radioactivity; or significant radioactive exposure ( ≥ 2 CT chest/abdomen tests, or ≥ 3 all other types of X-rays test) within 1 year prior to the trail, or participated in radio-label trails;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Soochow University — Suzhou
Identifiers
NCT: NCT06576401 · HDM1002-104