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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Male Adult
• Intervention / Treatment: Drug: [14C]Donafenib

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The first affiliated hospital of suzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: [14C]Donafenib	Drug: [14C]Donafenib; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The percentage of radioactive dose of [14C] radiolabelled Donafenib recovered in urine, faeces and in total	from 0 hour to 240 hours after administration
Identification of the main metabolite and biotransformation pathway of Donafenib and investigation of metabolite in plasma by LC-RAM/HRMS	Proportion of different metabolites	from 0 hour to 240 hours after administration
Quantitive analysis of the concentrations of Donafenib in plasma using the validated LC-MS/MS to obtain pharmacokinetic data	The concentrations of Donafenib in plasma	from 0 hour to 240 hours after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Review the relationship between investigational products and all the abnormal and clinically significant findings	Up to 7 days (approx) from the start of administration

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 9, 2018
• Primary Completion (ACTUAL): December 18, 2018
• Study Completion (ACTUAL): December 18, 2018

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (ACTUAL): March 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2017-MB-DNFN-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No