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Completed

NCT Number: NCT04816123

The Mass Balance and Biotransformation of [14C]Donafenib in Healthy Adult Man

This study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]Donafenib orally in Chinese healthy adult male volunteers, revealing the overall pharmacokinetic characteristics of Donafenib in humans, and providing a reference for the rational administration.

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Key information

Conditions

Healthy Male Adult

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, 215006, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A healthy male adult.
  • Age is between 18 and 45, inclusive.
  • Body mass index is between 19 and 26, inclusive.
  • Voluntarily to provide informed consent form.
  • Willing and able to communicate with investigators and complete the trial according to clinical trial protocol.

Exclusion criteria

  • Any abnormal and clinical significant findings.
  • A positive examination result of HBsAg/HBeAg, HIV antibody and treponema pallidum antibody.
  • Volunteers who had participated in a radiolabeled clinical study or were exposed to significant levels of radiation for any reasons within the 12 months prior to the study.
  • Volunteers who had used of prescription or herbal products that may affect the drug metabolism within 30 days before the study.
  • Volunteers who had blood loss/donation up to 400 mL within 3 months before the screening, or received blood transfusion within 1 month.

Treatment and study plan

[14C]Donafenib

Drug

Each volunteers received a single 300 mg dose of [14C]donafenib (toluene sulfonic acid) containing a radioactivity dose of 120 μCi as an oral suspension, in fasting within 5 minutes.

Primary outcomes

  1. Quantitive analysis of whole radioactivity of excrement of orally administered [14]Donafenib in Chinese healthy adult male volunteers to obtain the mass balance data and the main excretion pathway in human body

    Time frame: from 0 hour to 240 hours after administration

    The percentage of radioactive dose of [14C] radiolabelled Donafenib recovered in urine, faeces and in total

  2. Identification of the main metabolite and biotransformation pathway of Donafenib and investigation of metabolite in plasma by LC-RAM/HRMS

    Time frame: from 0 hour to 240 hours after administration

    Proportion of different metabolites

  3. Quantitive analysis of the concentrations of Donafenib in plasma using the validated LC-MS/MS to obtain pharmacokinetic data

    Time frame: from 0 hour to 240 hours after administration

    The concentrations of Donafenib in plasma

Secondary outcomes

  1. Adverse Events

    Time frame: Up to 7 days (approx) from the start of administration

    Review the relationship between investigational products and all the abnormal and clinically significant findings

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

The Mass Balance and Biotransformation Study of [14C] Donafenib in Chinese Healthy Adult Male Volunteers

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 25, 2021
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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