NCT01048203

A Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy Subjects

An Open Label, Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Active Biotech AB · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single site, open label, single dose, non-randomized study in healthy male and female subjects. The subjects will be evaluated for plasma, urine and feces levels of 14C-ABR-215050 during 21 days.

Detailed description

As a part of the pharmacokinetic documentation, the metabolism and mass balance of 14C-ABR-215050 will be studied in healthy subjects. Female healthy subjects are included in the study in case of expanding the indication to female forms of cancer. In this study a single dose of 1.0 mg of the study drug will be administered orally as a solution under fasted conditions. The absorption and safety profiles for the oral water solution will also be documented.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ABR-215050	1 mg ABR-215050

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2010-01-13
• Last updated: 2014-08-27

Locations

1 site across 1 country: Sweden