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[14C] Study on Mass Balance and Biotransformation of STI-1558 in Healthy Chinese Adult Male Subjects

NCT05754411 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-12-07

No results posted yet for this study

Summary

This trial adopts a single-center, single-dose, single-period, non-randomized, open-label study design. It is planned to enroll 6\~8 healthy male subjects, and each subject receives single oral administration of drug solution containing 600mg/approximately 100µCi \[14C\]STI-1558 under fasting conditions on trial D1. The whole blood, plasma, urine and stool samples are collected at specified time points/intervals during the trial. The pharmacokinetic parameters of the total radioactivity in plasma and whole blood, the material concentration ratios of the total radioactivity in plasma and whole blood, and the material balances are obtained by testing the total radioactivity of \[14C\]STI-1558 in plasma, whole blood, urine and feces. Meanwhile, using isotope tracer and mass spectrometry techniques, the main pathways and characteristics of metabolism and elimination of STI-1558 in humans are obtained through the quantification of radioactive metabolite profiles and the structure identification of the main metabolites in plasma, urine and feces of the subjects. The entire duration of trial is expected to be 5 months.

Conditions

Interventions

DRUG

[14C]STI-1558

Fasting oral administration of 600 mg \[ 14C \] STI-1558 ( about 100 μCi ) solution.

Sponsors & Collaborators

  • Zhejiang ACEA Pharmaceutical 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
2023-05-15
Primary Completion
2023-06-22
Completion
2023-11-09

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 NCT05754411 on ClinicalTrials.gov