CompletedPhase 1

A Mass Balance Study of [14C] SHR6508 in Chinese Hemodialysis Subjects With Secondary Hyperparathyroidism

China5 participantsStarted 2024-12-23

Plain-language summary

The study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of \[14C\] SHR6508.

Who can participate

Age range

18 Years

Sex

ALL

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

. Be able and willing to provide a written informed consent form.
. Male subjects and postmenopausal women.
. Meet the Body Mass Index (BMI) standard.

Exclusion criteria

. Subjects with a history of cardiovascular diseases.
. Subjects with gastrointestinal diseases.
. Subjects with a history of surgery.
. Subjects with a history of blood loss.
. Abnormal blood pressure.
. Be allergic to a drug ingredient or component.
. Subject with a history of alcohol abuse and drug abuse
. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

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

Cumulative excretion of radioactivity

Timeframe: Day 1 to Day 168.

Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)

Timeframe: Day 1 to Day 6.

Trial details

NCT IDNCT06877247

SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-04

View on ClinicalTrials.gov More Secondary Hyperparathyroidism trials