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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Male Adult

Intervention / Treatment
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* Drug: [14C]Donafenib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: single arm with single dose of 300mg Donafenib, containing about 120μCi [14C]Donafenib
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]Donafenib<br> | Drug: [14C]Donafenib<br>* 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.<br>|

What is the study measuring?
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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 |