Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects
- Conditions
- Healthy Volunteers
- Interventions
- Drug: 14C-AB1010
- Registration Number
- NCT05200169
- Lead Sponsor
- AB Science
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 4
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 14C-AB1010 14C-AB1010 Oral solution of 14C radiolabelled AB1010 (200 mg per subject)
- Primary Outcome Measures
Name Time Method Radioactivity recovery 168 hours post-dose Cumulative Amount of Total Radioactivity Excreted in Urine. No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. No formal statistical analysis were performed for this study due to the small number of subjects, for which statistical inference is not meaningful.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Quotient Sciences
🇬🇧Nottingham, United Kingdom