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

Launched by SHANGHAI HENGRUI PHARMACEUTICAL CO., LTD. · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "A Mass Balance Study of [14C] SHR6508 in Chinese Hemodialysis Subjects With Secondary Hyperparathyroidism," is looking to understand how the drug SHR6508 is processed in the body after being given to male patients undergoing hemodialysis for secondary hyperparathyroidism. This condition occurs when the body produces too much parathyroid hormone, often due to kidney problems. The researchers want to see how the drug is absorbed, metabolized, and eliminated from the body.

To participate in this study, men aged between 65 and 74 who can provide written consent and meet specific health criteria are eligible. However, individuals with a history of heart or gastrointestinal diseases, recent surgeries, significant blood loss, high blood pressure, allergies to the drug’s ingredients, or issues with alcohol or drug use will not be able to take part. Participants can expect to be closely monitored during the trial to ensure safety and to collect important information about how the drug works in their bodies. This research is crucial for improving treatments for patients with similar health issues in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Be able and willing to provide a written informed consent form.
• • 2. Male subjects and postmenopausal women.
• • 3. Meet the Body Mass Index (BMI) standard.
• Exclusion Criteria:
• • 1. Subjects with a history of cardiovascular diseases.
• • 2. Subjects with gastrointestinal diseases.
• • 3. Subjects with a history of surgery.
• • 4. Subjects with a history of blood loss.
• • 5. Abnormal blood pressure.
• • 6. Be allergic to a drug ingredient or component.
• • 7. Subject with a history of alcohol abuse and drug abuse
• • 8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.