NCT02432664 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ODM-108: in Healthy Male Volunteers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 14, 2015

Primary Completion Date

April 22, 2016

Study Completion Date

April 22, 2016

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

Trial Locations (1)

PRA Health Sciences, Zuidlaren