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Completed

NCT Number: NCT06877247

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

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

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Key information

Conditions

Secondary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)

Jinan, Shandong, 250014, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[14C] SHR6508 Injection

Drug

[14C] SHR6508 injection.

Primary outcomes

  1. Cumulative excretion of radioactivity

    Time frame: Day 1 to Day 168.

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

    Time frame: Day 1 to Day 6.

Secondary outcomes

  1. Adverse Events (AEs)

    Time frame: About 24 weeks.

  2. Serious adverse Events (SAEs)

    Time frame: About 24 weeks.

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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