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

NCT01840423 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2015-04-01

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

ODM-104

ODM-104

DRUG

Placebo

Placebo

DRUG

Entacapone

entacapone + levodopa/carbidopa

DRUG

levodopa/carbidopa

entacapone + levodopa/carbidopa

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Rainard Fuhr, MD · Parexel

  • angela ruck, PhD · Orion Corporation, Orion Pharma

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01840423 on ClinicalTrials.gov