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

Zelgen Biopharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy Male Adult

Treatments

Drug: [14C]Donafenib

Study type

Interventional

Funder types

Industry

Identifiers

NCT04816123

2017-MB-DNFN-16

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.