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

NCT02418650 Phase 1 COMPLETED

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.

Details

Lead sponsor	Orion Corporation, Orion Pharma
Phase	Phase 1
Status	COMPLETED
Enrolment	12
Start date	2015-03
Completion	2015-06

Conditions

• Healthy

Interventions

• ODM-201 300 mg tablet
• intravenous14C-ODM-201
• 300 mg 14C-ODM-201 oral solution

Primary outcomes

• Amount of 14C-ODM-201 dose excreted and cumulative amount excreted in urine and faeces and total. Amount excreted and cumulative amount excreted in urine, faeces and total expressed as a percentage of the administered dose. — Urine and faecal samples are collected baseline (Day-1) 72 h post-dose after IV dosing and up-to 14 day post-dose after oral solution dosing

Countries

United Kingdom