A Mass Balance Study of [14C] SHR6508 in Chinese Hemodial... | NCT06877247

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

NCT06877247

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Mar 23, 2026Actual

Enrollment

5Actual

Phase

Phase 1

Conditions

Secondary Hyperparathyroidism

Interventions

[14C] SHR6508 Injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 23, 2024Actual

Primary Completion Date

Apr 4, 2025Actual

Completion Date

Oct 11, 2025Actual

First Submitted Date

Mar 10, 2025

First Submission Date that Met QC Criteria

Mar 10, 2025

First Posted Date

Mar 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2026

Last Update Posted Date

Mar 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
[14C] SHR6508 Injection Group	Experimental		Drug: [14C] SHR6508 Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[14C] SHR6508 Injection	Drug	[14C] SHR6508 injection.	[14C] SHR6508 Injection Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative excretion of radioactivity		Day 1 to Day 168.
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)		Day 1 to Day 6.

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events (AEs)		About 24 weeks.
Serious adverse Events (SAEs)		About 24 weeks.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)		Jinan	Shandong	250014	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006962	Hyperparathyroidism, Secondary

Ancestor Terms

ID	Term
D006961	Hyperparathyroidism
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided