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

Shanghai Hengrui Pharmaceutical Co., Ltd.5 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Secondary Hyperparathyroidism

Interventions

[14C] SHR6508 InjectionDRUG

\[14C\] SHR6508 injection.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Jinan, Shandong, China

Outcomes

Primary Outcomes

Cumulative excretion of radioactivity

Time frame: Day 1 to Day 168.

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

Adverse Events (AEs)

Time frame: About 24 weeks.

Serious adverse Events (SAEs)

Time frame: About 24 weeks.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.