NCT02418650

Mass Balance, Pharmacokinetics, Biotransformation and Bioavailability Study of ODM-201 in Healthy Male Subjects

A Two-Part Open-Label, Single-Centre Mass Balance, Pharmacokinetics, Biotransformation and Absolute Bioavailability Study of ODM-201 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: Male
• Age: 50 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A study to investigate absolute bioavailability of ODM-201 and to determine the mass balance and routes of excretion of ODM-201 in healthy volunteers.

Detailed description

6 healthy male subjects will be enrolled in part 1 and part 2 of the study, respectively

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ODM-201 300 mg tablet
DRUG	intravenous14C-ODM-201
DRUG	300 mg 14C-ODM-201 oral solution

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-05-01
• Completion: 2015-06-01
• First posted: 2015-04-16
• Last updated: 2015-06-23

Locations

1 site across 1 country: United Kingdom