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.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. 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.

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.

NCT IDNCT06877247

SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-04