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Dose-finding Pharmacokinetic Study in Healthy Males (COMDOS1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055936
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Brief Summary:
This is a phase I PK study in healthy males.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Levodopa Drug: Carbidopa Drug: ODM-104 Phase 1

Detailed Description:
This is a phase I, open, repeated dose, randomised PK study in healthy males. The study will consist of 4 parallel groups (Groups 1-4). All groups will have a crossover design with 4 treatment periods, each lasting for 7 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose-finding Study for Levodopa, Carbidopa and ODM-104 Test Formulations After Repeated Administration in Healthy Males
Actual Study Start Date : February 21, 2017
Actual Primary Completion Date : June 9, 2017
Actual Study Completion Date : June 9, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: levodopa with carbidopa lower doses
levodopa 50 mg, carbidopa 12,5 mg
Drug: Levodopa
Levodopa 50 mg or 100 mg or 150 mg
Other Name: Sinemet

Drug: Carbidopa
Carbidopa 12,5 mg or 25 mg or 65 mg

Experimental: levodopa with carbidopa and ODM-104
levodopa 50 mg or 100 mg or 150 mg, carbidopa 65 mg and ODM-104 50 mg or 100 mg
Drug: Levodopa
Levodopa 50 mg or 100 mg or 150 mg
Other Name: Sinemet

Drug: Carbidopa
Carbidopa 12,5 mg or 25 mg or 65 mg

Drug: ODM-104
ODM-104 50 mg or 100 mg

Experimental: levodopa with carbidopa higher doses
levodopa 150 mg, carbidopa 37,5 mg
Drug: Levodopa
Levodopa 50 mg or 100 mg or 150 mg
Other Name: Sinemet

Drug: Carbidopa
Carbidopa 12,5 mg or 25 mg or 65 mg

Active Comparator: levodopa 100 mg with carbidopa
levodopa 100 mg (levodopa IR), carbidopa 65 or 25 mg
Drug: Levodopa
Levodopa 50 mg or 100 mg or 150 mg
Other Name: Sinemet

Drug: Carbidopa
Carbidopa 12,5 mg or 25 mg or 65 mg




Primary Outcome Measures :
  1. Levodopa area under the concentration-time curve from time 0 to the 24 h PK sample (AUC0-24) [ Time Frame: During 24 hours ]
    Comparisons of the levodopa area under the curve in different treatment combinations


Secondary Outcome Measures :
  1. Fluctuation of levodopa Cmax/Cmin, tau [ Time Frame: 24 hours ]
    Explore fluctuation of levodopa Cmax/Cmin, tau

  2. Levodopa peak plasma concentration (Cmax) [ Time Frame: 24 hours ]
    Explore levodopa Cmax



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
  • Males between 18-65 years of age inclusive at screening.
  • Body mass index (BMI) between 19-30 kg/m2 (BMI = weight/height2) inclusive at screening.
  • Weight at least 55 kg inclusive at screening.
  • Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems, and no history of major gastrointestinal surgery).
  • Subject with a partner of childbearing potential agrees to use adequate contraception from the first dose of study treatment until 90 days after the last dose of study treatment. Adequate methods of contraception include: Hormonal contraceptives, barrier methods (condom, diaphragm, cervical cap, etc.) in combination with a spermicide, intrauterine device and sexual abstinence.
  • Subject agrees to not donate sperm from the first dose of study treatment until 90 days after the last dose of study treatment.

Exclusion Criteria:

  • Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease or cancer (except local non-melanoma skin cancer) within the previous 2 years.
  • 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.
  • Any clinically significant abnormal laboratory value or ECG (such as prolonged QTcF >450 ms or QRS >120 ms) that in the opinion of the investigator could interfere with the interpretation of study results or cause 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 the previous 2 years or a tendency for vasovagal reactions during blood sampling.
  • HR < 50 bpm or > 90 bpm in the supine position after 5 min rest at the screening visit.
  • At the screening visit:

    • systolic BP < 100 mmHg or > 140 mmHg in the supine position after 5 min rest
    • diastolic BP < 50 mmHg or > 90 mmHg in the supine position after 5 min rest.
  • Creatinine > 1.5 x upper limit of normal (ULN) and alanine aminotransferase or aspartate aminotransferase >1.25 x ULN at screening.
  • History of anaphylactic/anaphylactoid reactions.
  • 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 for 48 h before the first dose in each period until collection of the 24 h PK sample in the morning of day 8.
  • Use of caffeine-containing beverages more than 600 mg of caffeine/day and/or inability to refrain from using caffeine-containing beverages 24 h before the first levodopa administration on the PK day (day 7) until collection of the 24 h PK sample in the morning of day 8.
  • Blood donation or loss of a significant amount of blood (> 500 ml) within 90 days before the first study treatment administration.
  • Participation in another investigational drug study or administration of another investigational drug within 60 days before the first study treatment administration.
  • Veins unsuitable for repeated venipuncture or cannulation.
  • Predictable poor compliance or inability to communicate well with the study centre personnel.
  • Inability to participate in all treatment periods.

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): NCT03055936


Locations
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Germany
Nuvisan Pharma Services
Neu-Ulm, Germany, 89231
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
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Principal Investigator: Denis Strugala, DR.med. Nuvisan GmbH
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Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT03055936    
Other Study ID Numbers: 3112005
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Levodopa
Carbidopa
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