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Human Mass Balance and Biotransformation Study of [14C]Afuresertib

NCT05489744 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-05-15

No results posted yet for this study

Summary

This study adopts a single-center, single-dose, non-randomized, open-label design with a proposed enrollment of 6-10 healthy male subjects. After a single oral dose of approximately 125 mg/150 µCi \[14C\]Afuresertib tablets, blood, urine and fecal specimens are collected from each subject at defined time points/periods during the trial, and PK parameters, recovery, and excretion routes of \[14C\]Afuresertib in plasma are calculated by measuring the total radioactivity. The main metabolic and elimination pathways and characteristics of Afuresertib in human, as well as circulating metabolites with close to or higher than 10% of plasma total radioactivity exposure, are also identified by plasma, urine, and fecal radioactive metabolite profiles and major metabolite structure.

Conditions

  • Healthy Volunteer

Interventions

DRUG

[14C]Afuresertib

Suspension containing approximately 125 mg of Afuresertib (containing 150 µCi of \[14C\]Afuresertib) is administered orally on an empty stomach, with approximately 240 mL of water for suspending and drug taking.

Sponsors & Collaborators

  • Laekna Limited

    lead INDUSTRY

Principal Investigators

  • Liyan Miao · The First Affiliated Hospital of Soochow University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-08-06
Primary Completion
2022-10-21
Completion
2022-10-21

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 NCT05489744 on ClinicalTrials.gov