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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-09

Study Completion Date

2018-12-18

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.

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Detailed Description

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Conditions

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Healthy Male Adult

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single arm with single dose of 300mg Donafenib, containing about 120μCi \[14C\]Donafenib

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Nonrandomized and open labeled study

Study Groups

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[14C]Donafenib

Group Type EXPERIMENTAL

[14C]Donafenib

Intervention Type DRUG

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.

Interventions

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[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.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes