MedTrace Logo

Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of ODM-106 in Healthy Volunteers

NCT02393950 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-12-23

Study results available
· View outcomes & findings →

Summary

The study is a dose escalation study with 8 planned dose levels. The study is a 4-period crossover design where each healthy volunteer will be randomised to receive three dose levels of ODM-106 (single doses) and one dose of placebo. The study will look at the pharmacokinetics (how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-106.

Conditions

  • Healthy Volunteer Study

Interventions

DRUG

ODM-106

Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo.

DRUG

Placebo

Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo.

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Rainard Fuhr, MD · Parexel International GmbH, Berlin, Germany

  • John Whiteside · Orion Corporation, Orion Pharma

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-10-31
Completion
2016-03-31

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 NCT02393950 on ClinicalTrials.gov