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Mass Balance Study of [14C] D-1553 in Chinese Healthy Adult Male Subjects

NCT06233916 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-02-01

No results posted yet for this study

Summary

* To quantitatively analyze the total radioactivity (TRA) in excrement after a single oral dose of \[14C\] D-1553 in healthy subjects, and obtain radioactivity recovery and primary excretion pathways in humans;
* To obtain radioactive metabolite profiles of human plasma, urine and feces , identify major metabolites of D-1553 and determine the major metabolic pathways and elimination pathways;
* To quantitatively analyze the TRA in whole blood and plasma and obtain PK parameters of plasma TRA and investigate whole blood/plasma ratio for TRA.

Conditions

  • Mass Balance Study

Interventions

DRUG

[14C] D-1553

\[14C\] D-1553 (approximately 400 mg/80 μCi)

Sponsors & Collaborators

  • InventisBio Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-08
Primary Completion
2024-01-03
Completion
2024-01-10
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06233916 on ClinicalTrials.gov