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Mass Balance Study of TQB3616

NCT06149611 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-11-29

No results posted yet for this study

Summary

This is a clinical study exploring the mass balance of \[14C\] TQB3616 in healthy Chinese subjects aims to quantitatively analyze the total radioactivity in the feces of male healthy subjects after oral administration of \[14C\] TQB3616, obtain data on human radiation excretion rate and main excretion pathways, investigate the distribution in whole blood and plasma, plasma distribution, and pharmacokinetics of total radioactivity in plasma, identify main metabolites, and determine the main biological transformation pathways, obtain the pharmacokinetic parameters of TQB3616 and its metabolites in plasma. The primary endpoint is mass balance, radiopharmacokinetics, plasma pharmacokinetics, and metabolites.

Conditions

Interventions

DRUG

[14C] TQB3616

TQB3616 is a new type of cyclin-dependent kinase (CDK) 4/6 inhibitor.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06149611 on ClinicalTrials.gov