Pharmacokinetic of Levodopa Study in Healthy Males
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
Levodopa, carbidopa, ODM-104
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Written informed consent (IC) obtained.
- Finnish speaking males between 18-65 years of age.
- Body mass index (BMI) between 19-32 kg/m2 (BMI = weight/height2).
- Weight at least 60 kg.
- Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems, and no history of major gastrointestinal surgery).
- Sexually active study subjects, unless surgically sterile 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) and must not donate sperm from the first study treatment administration until 3 months after the last study treatment administration.
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 < 40 beats per minute (bpm) or > 90 bpm in the supine position after 5 min rest at the screening visit.
- At the screening visit:systolic BP < 90 mmHg or > 150 mmHg in the supine position after 5 min rest and diastolic BP < 50 mmHg or > 90 mmHg in the supine position after 5 min rest.
- 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 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 using caffeine containing beverages 10 h before and during the study periods.
- Blood donation or loss of a significant amount of blood within 90 days before the first study treatment administration.
- Participation in an investigational drug study or administration of an investigational drug within 90 days before the first study treatment administration.
- Unsuitable veins 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.
Sites / Locations
- Clinical Pharmacology Unit, Orion Pharma
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Experimental
Active Comparator
Active Comparator
Arm Label
Levodopa formulation D
Levodopa formulation E
Levodopa formulation F
Sinemet IR 100/25mg
Sinemet CR 100/25mg
ODM-104 100mg
Carbidopa 20mg
Carbidopa 65mg
Arm Description
Levodopa formulation D
Levodopa formulation E
Levodopa formulation F
Sinemet IR 100/25MG
Sinemet IR 100/25MG
ODM-104 100MG
Carbidopa 20MG
Carbidopa 65MG
Outcomes
Primary Outcome Measures
Pharmacokinetics (Cmax) of levodopa
Peak Plasma Concentration (Cmax)
Secondary Outcome Measures
Full Information
NCT ID
NCT03140956
First Posted
April 12, 2017
Last Updated
September 25, 2017
Sponsor
Orion Corporation, Orion Pharma
1. Study Identification
Unique Protocol Identification Number
NCT03140956
Brief Title
Pharmacokinetic of Levodopa Study in Healthy Males
Official Title
Pharmacokinetics of Levodopa After Repeated Doses of Different Pellet Formulations; An Open, Randomized Study With Crossover Design in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
July 3, 2017 (Actual)
Study Completion Date
August 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orion Corporation, Orion Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to investigate PK of levodopa in plasma after repeated doses of 3 levodopa formulations given in combination with carbidopa and ODM-104 and compared to the PK of standard IR and CR levodopa formulations in the same combination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levodopa formulation D
Arm Type
Experimental
Arm Description
Levodopa formulation D
Arm Title
Levodopa formulation E
Arm Type
Experimental
Arm Description
Levodopa formulation E
Arm Title
Levodopa formulation F
Arm Type
Experimental
Arm Description
Levodopa formulation F
Arm Title
Sinemet IR 100/25mg
Arm Type
Active Comparator
Arm Description
Sinemet IR 100/25MG
Arm Title
Sinemet CR 100/25mg
Arm Type
Active Comparator
Arm Description
Sinemet IR 100/25MG
Arm Title
ODM-104 100mg
Arm Type
Experimental
Arm Description
ODM-104 100MG
Arm Title
Carbidopa 20mg
Arm Type
Active Comparator
Arm Description
Carbidopa 20MG
Arm Title
Carbidopa 65mg
Arm Type
Active Comparator
Arm Description
Carbidopa 65MG
Intervention Type
Drug
Intervention Name(s)
Levodopa, carbidopa, ODM-104
Other Intervention Name(s)
Sinemet
Intervention Description
Crossover design. Study treatments will be administered in randomized order 4 times a day.
Primary Outcome Measure Information:
Title
Pharmacokinetics (Cmax) of levodopa
Description
Peak Plasma Concentration (Cmax)
Time Frame
24 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Written informed consent (IC) obtained.
Finnish speaking males between 18-65 years of age.
Body mass index (BMI) between 19-32 kg/m2 (BMI = weight/height2).
Weight at least 60 kg.
Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems, and no history of major gastrointestinal surgery).
Sexually active study subjects, unless surgically sterile 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) and must not donate sperm from the first study treatment administration until 3 months after the last study treatment administration.
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 < 40 beats per minute (bpm) or > 90 bpm in the supine position after 5 min rest at the screening visit.
At the screening visit:systolic BP < 90 mmHg or > 150 mmHg in the supine position after 5 min rest and diastolic BP < 50 mmHg or > 90 mmHg in the supine position after 5 min rest.
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 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 using caffeine containing beverages 10 h before and during the study periods.
Blood donation or loss of a significant amount of blood within 90 days before the first study treatment administration.
Participation in an investigational drug study or administration of an investigational drug within 90 days before the first study treatment administration.
Unsuitable veins 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.
Facility Information:
Facility Name
Clinical Pharmacology Unit, Orion Pharma
City
Espoo
ZIP/Postal Code
02200
Country
Finland
12. IPD Sharing Statement
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Pharmacokinetic of Levodopa Study in Healthy Males
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