Mass Balance Study of [14C] D-2570 | NCT07411742

Studies
Mass Balance Study of [14C] D-2570

NCT07411742

Sponsor

InventisBio Co., Ltd

Status

Active, not recruiting

Last Update Posted

Apr 29, 2026Actual

Enrollment

8Estimated

Phase

Phase 1

Conditions

Mass Balance Study

Interventions

[14C] D-2570 group

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

Feb 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2026Actual

Primary Completion Date

Mar 31, 2026Actual

Completion Date

Aug 31, 2026Estimated

First Submitted Date

Feb 9, 2026

First Submission Date that Met QC Criteria

Feb 9, 2026

First Posted Date

Feb 17, 2026Actual

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

Apr 23, 2026

Last Update Posted Date

Apr 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Radiolabeled drug substance balance clinical studies are commonly used methods to elucidate the metabolic and excretion characteristics of drugs in the human body. They are widely applied in the research and development of innovative drugs both domestically and internationally, and their safety has been validated through extensive human trials. The primary objectives of this study are as follows:

To quantitatively analyze the total radioactive activity (TRA) in urine and feces, thereby determining the radioactive recovery rate in humans and identifying the primary excretion pathways. To obtain radioactive metabolite profiles in human plasma, urine, and feces, identify the major metabolites, and determine the principal metabolic and elimination pathways. To quantitatively analyze the total radioactive activity in whole blood and plasma, derive the pharmacokinetic parameters for total radioactivity in plasma and whole blood (if applicable), and investigate the distribution of total radioactivity between whole blood and plasma.

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

8Estimated

Label	Type	Description	Intervention Names
[14C] D-2570 group	Experimental		Drug: [14C] D-2570 group

Name	Type	Description	Arm Group Labels	Other Names
[14C] D-2570 group	Drug	[14C] labeled D-2570	[14C] D-2570 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of unchanged drug and its metabolites in plasma, urine and feces to the administered dose		2 weeks
Total recovery in excrement (the ratio of the radioactivity in excrement samples to the radioactivity of the administered drug)		2 weeks
Total Radioactivity of D-2570 in Plasma and Whole Blood		baseline to 2 weeks
Whole blood/plasma ratio for TRA (total radioactivity) at different time points		Baseline to 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Incidence and severity of AEs based on NCI CTCAE V6.0		Baseline to 3 weeks
Blood concentration of D-2570		Baseline to 2 weeks
Blood concentration of D-2570 metabolites (if applicable)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject must voluntarily participates in this study after full informed consent.
Chinese male healthy subjects aged 18-45 years (inclusive) at the time of signing the ICF
At screening, subject's body weight is ≥50.0 kg, with a body mass index (BMI) between 19.0 kg/m² and 26.0 kg/m² (inclusive)
Subjects have no plans for reproduction or sperm donation during the trial and for 6 months after study drug administration. Subjects agree to practice complete abstinence, have undergone sterilization surgery, or agree to use effective contraception from the time of ICF signing throughout the entire study period until 6 months after study drug administration.

Exclusion Criteria:

Findings from screening assessments judged by the investigator as abnormal and clinically significant
History of infection as defined in the protocol.
Any of the medical diseases or disorders listed in the protocol.
Unable to comply with the lifestyle restrictions stipulated in the protocol.
Medication history does not meet the requirements of the protocol.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Meng Wang	Second Affiliated Hospital of Soochow University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital of Soochow University		Suzhou	Jiangsu		China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided