NCT02432664

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ODM-108: in Healthy Male Volunteers

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Single and Multiple Escalating Doses of ODM-108: A Single Centre Study in Healthy Male Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to investigate to what extent this new study drug is tolerated in humans. The study is divided into 3 parts (Part III is optional and may go ahead depending on the results of Parts I and II). The volunteers will only be enrolled to one part of the study. In parts I and II the volunteer will receive active study drug or placebo. In part I the volunteers will receive a single dose of one of the eight planned escalating dose levels. In part II volunteers will receive 4 planned dose levels based on the results obtained in Part 1 of the study, with the option to include an additional dosing group. In optional part III the volunteer will receive ODM-108 and an already registered drug so that interactions with other drugs can be studied. It will be investigated how quickly and to what extent the study drug is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, in parts I and II the effect of the compound on the sensation of pain and on cognition (activities of thinking, understanding, learning, and remembering) will be investigated (this is called pharmacodynamics).

Detailed description

This is the first time that this compound is being given to humans. The study will only take place after it has been approved by the Independent Ethics Committee.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ODM-108 Part I	Single oral escalating dose of ODM-108. Each volunteer will receive either one dose of ODM-108 or placebo
DRUG	Placebo Part I	Single oral escalating dose of ODM-108. Each volunteer will receive either one dose of ODM-108 or placebo
DRUG	ODM-108-Part II	Multiple escalating doses based on the results of Part 1. Either ODM-108 or placebo 1 - 4 times a day for 7 days
DRUG	Placebo Part II	Multiple escalating doses based on the results of Part 1. Either ODM-108 or placebo 1 - 4 times a day for 7 days
DRUG	ODM-108 Part III	Oral capsules 1 - 4 times daily for 7 to 10 days
DRUG	Midazolam	Single dose as a solution 3 days prior to the first dose of ODM-108 and on the last day of dosing with ODM-108

Timeline

• Start date: 2015-04-14
• Primary completion: 2016-04-22
• Completion: 2016-04-22
• First posted: 2015-05-04
• Last updated: 2017-07-02

Locations

1 site across 1 country: Netherlands