Healthy Male Adult
Conditions
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.
Interventions
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.
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
Nonrandomized and open labeled study
Intervention model description
single arm with single dose of 300mg Donafenib, containing about 120μCi \[14C\]Donafenib
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed