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

Phase 1

Completed

• Conditions: Healthy Male Adult
• Interventions: Drug: [14C]Donafenib

• Registration Number: NCT04816123
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-09
• Primary Completion: 2018-12-18
• Study Completion: 2018-12-18
• Status Verified: 2021-03
• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-24
• Last Update Submitted: 2021-03-24
• Study First Posted: 2021-03-25
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]Donafenib	[14C]Donafenib	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Suzhou University; 🇨🇳 Suzhou, Jiangsu, China