A Study to Evaluate the Mass Balance of [14C] SY-5007 in Healthy Adult Male Subjects in China (NCT06352190) | Clinical Trial Compass
UnknownPhase 1
A Study to Evaluate the Mass Balance of [14C] SY-5007 in Healthy Adult Male Subjects in China
China8 participantsStarted 2024-05-01
Plain-language summary
This is a single-center, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled SY-5007 administered orally.
Who can participate
Age range
18 Years – 50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Fully informed, able to communicate effectively with researchers, agree to abide by the protocol and trial management regulations, and voluntarily sign the written Informed Consent Form (ICF);
. Healthy adult males aged 18 to 50 years at the time of signing the ICF, with no plans for reproduction or sperm donation within the past 2 years;
. Weight ≥ 50 kg and body mass index (BMI) between 18 and 26 kg/m2;
. Subjects of reproductive capability agree to employ effective contraceptive measures with their sexual partners during the study period and for 2 years following the end of the study.
Exclusion criteria
. History of allergies (such as allergies to two or more drugs, foods, or pollen, or individuals prone to skin hives or allergic reactions).
. Positive for hepatitis B surface antigen, hepatitis C virus antibodies, human immunodeficiency virus antibodies, or positive for syphilis treponemal and non-treponemal antibodies during screening.
. Abnormal clinically significant vital signs, physical examinations, laboratory tests, or electrocardiograms at screening.
. Gastrointestinal, hepatic, or renal diseases that may affect drug pharmacokinetics as assessed by the investigator at screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total radioactivity in plasma PK: Cmax
Timeframe: At pre-dose and up to 2 weeks post-dose
2
Total radioactivity in plasma PK: Tmax
Timeframe: At pre-dose and up to 2 weeks post-dose
3
Total radioactivity in plasma PK: AUC0-t
Timeframe: At pre-dose and up to 2 weeks post-dose
4
Total radioactivity in plasma PK: t½
Timeframe: At pre-dose and up to 2 weeks post-dose
5
Total radioactivity in plasma PK: CL/F
Timeframe: At pre-dose and up to 2 weeks post-dose
6
Whole blood to plasma total radioactivity ratio
Timeframe: At pre-dose and up to 2 weeks post-dose
7
Cumulative total radioactivity in urine and faeces
Timeframe: At pre-dose and up to 2 weeks post-dose
. History of drug abuse or illicit drug use within 12 months prior to the first dose administration, or positive urine drug screening test during screening.
. Underwent major surgery within 6 months prior to the first dose administration, or planned to undergo surgery during the trial period.
. History of any clinically significant illness within 3 months prior to the first dose administration or conditions deemed by the investigator to potentially affect trial outcomes, including but not limited to cardiovascular, endocrine, nervous, respiratory, digestive, urinary, hematologic, immune, or psychiatric disorders.
. Average daily smoking of more than 5 cigarettes within 3 months prior to the first dose administration, or unwillingness to discontinue use of any tobacco products during the trial.
Metabolic profiling in plasma, urinary and fecal excretion
Timeframe: At pre-dose and up to 2 weeks post-dose