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The Absorption, Metabolism and Excretion of [14C]CM082 in Human

NCT04434326 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-11-14

No results posted yet for this study

Summary

This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of \[14C\] CM082 in healthy Chinese male subjects. The study will be conducted into two steps：Firstly, 2 subjects are enrolled in to participate in the pilot study to grope for the completion date of plasma, urine and feces sampling on the 3rd day post-dose and onwards. Then, the collection time of blood and excreta samples (urine and feces) from the subsequent 4-6 subjects will be adjusted according to the pilot study

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

[14]CM082 suspension

Before administration, the solid powder for administration was placed at room temperature. 40 ml drinking water was added into the drug container to prepare the suspension for the subjects to take. After that, 200 ml drinking water was used to repeatedly rinse the drug container for many times, and the subjects continued to take the lotion. Take care not to spill the liquid out of the bottle when shaking

Sponsors & Collaborators

  • AnewPharma

    lead INDUSTRY

Principal Investigators

  • Feng Shao, Ph D · Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine

  • Wei Liu, M.A · Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine

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
2021-07-05
Primary Completion
2021-10-22
Completion
2021-10-22

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 NCT04434326 on ClinicalTrials.gov