Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-103 in Healthy Volunteers (NOCOS)

September 18, 2014 updated by: Orion Corporation, Orion Pharma

Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Repeated Escalating Doses of ODM-103: a Randomised, Double-blind, Placebo- and Entacapone-controlled Single Centre First-in-man Study in Healthy Volunteers.

The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-103 when given to healthy male volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is divided into two parts. Part one is a crossover study where healthy volunteers will receive two doses of ODM-103 and one dose of placebo. Part II of the study is a multiple ascending dose parallel group study where healthy volunteers will receive ODM-103 three times daily for seven days. Healthy volunteers taking part in Part II of the study will also receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in addition to ODM-103 on day 9. The study will also look at the pharmacokinetic(how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-103.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Parexel International GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male subjects aged between 18 and 45 years
  • BMI 18-30 kg/m2
  • Weight 55-90kg
  • Written informed consent
  • Good General Health

Exclusion Criteria:

  • Vulnerable subjects
  • Veins unsuitable for repeated venipuncture
  • Evidence of clinically significant cardiovascular, renal, hepatic, hematological, Gi, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disorder
  • History of or positive test for drug abuse
  • Any condition requiring regular concomitant medication
  • Blood donation or significant loss of blood within 3 months prior to screening
  • Abnormal 12 lead ECG finding of clinical relevance
  • Heart rate (HR) <50bpm or >90bpm after 10 minutes in a supine position
  • Systolic blood pressure <90mmHg or >140mmHg after 10 minutes in a supine position
  • Diastolic blood pressure <50mmHg or >90mmHg after 10 minutes in a supine position
  • Abnormal 24 hour Holter recording of clinical relevance at screening
  • Any abnormal laboratory value, vital signs or physical examination causing a health risk to the volunteer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ODM-103
Oral capsules dosage 10-800mg once daily for one day or three times daily for 7 days
Drug: ODM103
Placebo Comparator: Placebo
Oral capsules given once daily for one day or three times daily for 7 days
Drug: Placebo
Active Comparator: entacapone + levodopa/carbidopa
entacapone: oral tablet 200mg given four times daily for one day; levodopa/carbidopa: oral tablet 100/25mg given four times daily for one day
Drug: Entacapone
Drug: Levodopa/carbidopa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erythrocyte Catechol-O-methyltransferase (COMT) inhibition.
Time Frame: 0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose
Maximal COMT inhibition and area under the COMT inhibition curve (AUCC)
0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration curve (AUC)
Time Frame: 0, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2, 4, 6, 10, 16, 24h post dose
AUC under the plasma concentration curve
0, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2, 4, 6, 10, 16, 24h post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 30, 2012

First Submitted That Met QC Criteria

September 14, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3109001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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