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

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ClinicalTrials.gov Identifier: NCT01840423
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: ODM-104 Drug: Placebo Drug: Entacapone Drug: levodopa/carbidopa Phase 1

Detailed Description:
The study is divided into two parts. Part one is a crossover study where healthy volunteers will receive two doses of ODM-104 and one dose of placebo. Part II of the study is a multiple ascending dose parallel group study where healthy volunteers will receive ODM-104 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-104 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-104.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Repeated Escalating Doses of ODM-104: a Randomised, Double-blind, Placebo- and Entacapone-controlled Single Centre First-in-man Study in Healthy Volunteers.
Study Start Date : May 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ODM-104
Oral capsules dosage 10-800mg once daily for one day or three times daily for 7 days
Drug: ODM-104
ODM-104

Placebo Comparator: Placebo
Oral capsules given once daily for one day or three times daily for 7 days
Drug: Placebo
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
entacapone + levodopa/carbidopa

Drug: levodopa/carbidopa
entacapone + levodopa/carbidopa




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male subjects aged between 18 and 45 years
  • BMI 18-30 kg/m2
  • Weight 55-95kg
  • 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 2 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840423


Locations
Germany
Parexel International GmbH
Berlin, Germany
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Rainard Fuhr, MD Parexel
Study Director: angela ruck, PhD Orion Corporation, Orion Pharma

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01840423     History of Changes
Other Study ID Numbers: 3112001
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Orion Corporation, Orion Pharma:
First in man study
Volunteer study

Additional relevant MeSH terms:
Levodopa
Carbidopa
Entacapone
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Catechol O-Methyltransferase Inhibitors