The Absorption, Metabolism and Excretion of [14C] HQP1351 in Humans

NCT04126707 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-09-08

No results posted yet for this study

Summary

The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 30mg (100µCi) dose of \[14C\] HQP1351 given as a suspension. For further clinical development, human mass balance data are required to elucidate the absorption, metabolism, and excretion of HQP1351.

Conditions

  • Chronic Myeloid Leukemia (CML)

Interventions

DRUG

[14C] HQP1351

Orally, single dose of 30mg

Sponsors & Collaborators

  • HealthQuest Pharma Inc.

    collaborator INDUSTRY
  • Ascentage Pharma Group Inc.

    lead INDUSTRY

Principal Investigators

  • Feng Shao, Doctor · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-11-19
Primary Completion
2020-01-13
Completion
2020-01-13

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 NCT04126707 on ClinicalTrials.gov