NCT01840423

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers

Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Repeated Escalating Doses of ODM-104: a Randomised, Double-blind, Placebo- and Entacapone-controlled Single Centre First-in-man Study in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-104 when given to healthy male volunteers.

Detailed description

The study is divided into two parts. Part one is a crossover study where healthy volunteers will receive two doses of ODM-104 and one dose of placebo. Part II of the study is a multiple ascending dose parallel group study where healthy volunteers will receive ODM-104 three times daily for seven days. Healthy volunteers taking part in Part II of the study will also receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in addition to ODM-104 on day 9. The study will also look at the pharmacokinetic(how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-104.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ODM-104	ODM-104
DRUG	Placebo	Placebo
DRUG	Entacapone	entacapone + levodopa/carbidopa
DRUG	levodopa/carbidopa	entacapone + levodopa/carbidopa

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-04-25
• Last updated: 2015-04-01

Locations

1 site across 1 country: Germany