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
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