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

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).

Conditions

• Healthy

Interventions

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

Sponsors & Collaborators

• PRA Health Sciences

  collaborator INDUSTRY

• Orion Corporation, Orion Pharma

  lead INDUSTRY

Principal Investigators

• Sjoerd van Marle, M.D · PRA Health Sciences

• Sara Haworth · Orion Corporation, Orion Pharma

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-04-14

Primary Completion

2016-04-22

Completion

2016-04-22

Countries

• Netherlands

Study Locations