NCT05200169

Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects

An Open-Label, Non-Randomised, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: AB Science · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To assess the mass balance recovery after a single oral dose of 14C-AB1010

Detailed description

The objective is to characterize the distribution, metabolism and elimination of AB1010 in humans through the sampling of blood, urine, and faeces. This is accomplished through the administration of 14C-AB1010 oral solution with a therapeutic relevant dose of AB1010 as a single oral dose. There was no control group and no blinding as the objective was to assess the mass balance of masitinib after a single oral intake. There was only one group of healthy male volunteers.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	14C-AB1010	Oral solution of 14C radiolabelled AB1010 (200 mg per subject)

Timeline

• Start date: 2017-07-31
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2022-01-20
• Last updated: 2022-01-21

Locations

1 site across 1 country: United Kingdom