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Pharmacokinetic Study in Healthy Males (NOCOF)

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ClinicalTrials.gov Identifier: NCT02312232
Recruitment Status : Completed
First Posted : December 9, 2014
Last Update Posted : February 18, 2015
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Brief Summary:
The purpose of this study is to investigate the pharmacokinetics of levodopa, carbidopa, 3-OMD and ODM-104 after repeated doses of 3 levodopa formulations given in combination with carbidopa and ODM-104.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: levodopa, carbidopa, ODM-104 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Levodopa, Carbidopa, 3-OMD and ODM-104 After Repeated Doses of Different Formulations: an Open, Randomised, Multicentre Study With Crossover Design in Healthy Males
Study Start Date : November 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levodopa formulation A
Levodopa formulation A together with ODM-104 100 mg and carbidopa
Drug: levodopa, carbidopa, ODM-104
Other Name: Sinemet

Experimental: levodopa formulation B
levodopa formulation B together with ODM-104 100 mg and carbidopa
Drug: levodopa, carbidopa, ODM-104
Other Name: Sinemet

Experimental: levodopa formulation C
levodopa formulation C together with ODM-104 100 mg and carbidopa
Drug: levodopa, carbidopa, ODM-104
Other Name: Sinemet

Active Comparator: Sinemet IR 100/25 mg
Sinemet IR 100/25 mg together with ODM-104 100 mg
Drug: levodopa, carbidopa, ODM-104
Other Name: Sinemet

Active Comparator: Half Sinemet CR 100/25 mg
Half Sinemet CR 100/25 mg together with ODM-104 100 mg
Drug: levodopa, carbidopa, ODM-104
Other Name: Sinemet




Primary Outcome Measures :
  1. Pharmacokinetics (Cmax) of levodopa [ Time Frame: 24 hours ]
    Peak Plasma Concentration (Cmax)


Secondary Outcome Measures :
  1. Pharmacokinetics (Cmax) of carbidopa, 3-OMD and ODM-104 [ Time Frame: 24 hours ]
    Peak Plasma Concentration (Cmax)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent (IC) obtained.
  • Good general health ascertained by detailed medical history and physical examinations.
  • Finnish speaking males 18-65 years of age (inclusive).
  • Normal weight defined as a body mass index (BMI) > 19 and < 32 kg/m2 (BMI = weight/height2).
  • Weight at least 60 kg.
  • Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems).
  • Participants with female partners of child-bearing potential must adhere to a proper form of contraception (hormonal contraception or intrauterine device on female partner, and an additional barrier method used at least by one of the partners) from the first study treatment administration until 3 months after the end-of-study visit.

Exclusion Criteria:

  • Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, malignancy, neurological or psychiatric disease within the previous 2 years.
  • Inherited or family history (parents, siblings) of clinically significant cardiac conduction disease.
  • Current/history of inflammatory bowel disease (IBDs): Colitis ulcerosa and Crohn's disease, celiac disease. Acute duodenal or gastric ulcer or gastritis, esophagitis, colon polyps or anal fissure.
  • Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol for occasional pain is allowed.
  • Intake of any medication that could affect the outcome of the study.
  • Any clinically significant abnormal laboratory value or physical finding (including ECG and vital signs) that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject if he takes part in the study.
  • Known hypersensitivity to the active substances or the excipients of the drugs.
  • History of vasovagal collapses or vagal reactions with unexplained reason within 2 years or a tendency for vasovagal reactions during blood sampling.
  • History of sleep apnea.
  • Heart rate (HR) < 40 bpm or > 90 bpm after 10 minutes in supine position at the screening visit and predose.
  • At the screening visit:

systolic blood pressure (BP) < 90 mmHg or > 150 mmHg after 10 minutes in supine position diastolic BP < 50 mmHg or > 90 mmHg after 10 minutes in supine position

  • Abnormal 24-hour Holter findings of clinical relevance according to cardiologist´s assessment at the screening visit.
  • History of anaphylactic/anaphylactoid reactions.
  • History of seizures excluding febrile seizures during the first 6 years of life.
  • Strong tendency to motion sickness.
  • Recent or current (suspected) drug abuse.
  • Recent or current alcohol abuse; regular drinking of more than 21 units per week (1 unit = 4 cl spirits or equivalent).
  • Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine containing products during the study (from the screening visit to the end-of-study visit).
  • Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from the use of caffeine containing beverages during the treatment periods until 24 hours after study treatment administration.
  • Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.
  • Administration of another investigational drug within 90 days prior to the first study treatment administration.
  • Unsuitable veins for repeated venipuncture or for cannulation.
  • Predictable poor compliance or inability to communicate well with the study centre personnel.
  • Inability to participate in all treatment periods.
  • Participation in a clinical drug study during or within 3 months prior to the first study treatment administration.

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): NCT02312232


Locations
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Finland
CRST
Turku, Finland, 20520
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Principal Investigator: Mika Scheinin, MD CRST Turku

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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT02312232     History of Changes
Other Study ID Numbers: 3112002
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
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Carbidopa
Carbidopa, levodopa drug combination
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
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
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists