Status:
ACTIVE_NOT_RECRUITING
A Mass Balance Study of [14C] SHR6508 in Chinese Hemodialysis Subjects With Secondary Hyperparathyroidism
Lead Sponsor:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Conditions:
Secondary Hyperparathyroidism
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of \[14C\] SHR6508.
Eligibility Criteria
Inclusion
- Be able and willing to provide a written informed consent form.
- Male subjects and postmenopausal women.
- Meet the Body Mass Index (BMI) standard.
Exclusion
- 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.
Key Trial Info
Start Date :
December 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06877247
Start Date
December 19 2024
End Date
September 1 2025
Last Update
April 17 2025
Active Locations (1)
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1
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
Jinan, Shandong, China, 250014