Levodopa Concentration Profile With Stalevo 75/125 mg (NEWSTA)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
Stalevo (levodopa/ carbidopa/ entacapone)
Sinemet (levodopa/carbidopa)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Pharmacokinetic
Eligibility Criteria
Inclusion Criteria:
- Written informed consent (IC) obtained.
- Good general health ascertained by detailed medical history, and laboratory and physical examinations.
- Finnish speaking males or females, 18-70 years of age inclusive.
- Normal weight defined as body mass index (BMI) 18.5-30.0 kg/m2 (inclusive) (BMI = weight/height2).
- Weight at least 50.0 kg.
- Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems).
Exclusion Criteria:
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator.
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, contraceptives or hormone replacement therapy are allowed.
- Intake of any medication that could affect the outcome of the study.
- Any clinically significant abnormal laboratory value or physical finding (including electrocardiogram [ECG]) and vital signs) that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study, as judged by the investigator.
- Orthostatic hypotension; systolic and diastolic BP and heart rate HR after 3 minutes in supine position and after 3 minutes of standing:
- decrease of ≥ 20 mmHg for systolic BP
- decrease of ≥ 10 mmHg for diastolic BP.
- Strong tendency to motion sickness.
- Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
- Pregnant or lactating females.
- Females of childbearing potential if they are not using proper contraception (hormonal contraception, intrauterine device (IUD) or surgical sterilization, spermicidal foam/Vagitorie, condom on male partner). Double methods (mentioned above) of contraception is needed during the study. (Note: women of childbearing potential with no current sexual relationship can be included without contraception according to the judgement of the investigator).
- Recent or current (suspected) drug abuse or positive result in the drug abuse test.
- Recent or current alcohol abuse (regular drinking more than 21 units per week for males and more than 16 units per week for females [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 stay at the study centre.
- Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from the use of caffeine containing beverages while at the study centre.
- Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.
- Administration of another investigational treatment 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.
Sites / Locations
- Phase I Unit, Orion Pharma
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Stalevo (levodopa/carbidopa/entacapone)
Sinemet (levodopa/carbidopa)
Arm Description
125mg or 75mg of levodopa during treatment period 1 in groups 1 and 2 respectively. 150mg or 100mg of levodopa during treatment period 2 in groups 1 and 2 respectively.
150mg or 100mg of levodopa during treatment period 3 in study groups 1 and 2 respectively
Outcomes
Primary Outcome Measures
To demonstrate that reduced Stalevo strengths 75 mg and 125 mg following initial 100 mg and 150 mg strengths, will not increase Cmax of levodopa compared to Stalevo or levodopa/carbidopa dosing using equal strengths during the day.
Secondary Outcome Measures
Cmin, AUCo-tau
Full Information
NCT ID
NCT01070628
First Posted
November 23, 2009
Last Updated
August 12, 2010
Sponsor
Orion Corporation, Orion Pharma
1. Study Identification
Unique Protocol Identification Number
NCT01070628
Brief Title
Levodopa Concentration Profile With Stalevo 75/125 mg
Acronym
NEWSTA
Official Title
Levodopa Concentration Profile After Repeated Doses of Different Stalevo® Strengths With 3.5 Hours Dosing Frequency; an Open, Randomised, Crossover, Levodopa/Carbidopa Controlled Single Centre Study in Healthy Subjects, Two Parallel Groups
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Orion Corporation, Orion Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to confirm that the dose levels and dosing frequency utilising the new Stalevo strengths would result into more stable levodopa plasma levels. Therefore, it is anticipated that when lower dose of Stalevo is administered after the first higher dose of Stalevo, this would result in equally high levodopa maximum concentration values (Cmax) after each dose throughout the day compared to Cmax after the first dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Pharmacokinetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stalevo (levodopa/carbidopa/entacapone)
Arm Type
Experimental
Arm Description
125mg or 75mg of levodopa during treatment period 1 in groups 1 and 2 respectively.
150mg or 100mg of levodopa during treatment period 2 in groups 1 and 2 respectively.
Arm Title
Sinemet (levodopa/carbidopa)
Arm Type
Active Comparator
Arm Description
150mg or 100mg of levodopa during treatment period 3 in study groups 1 and 2 respectively
Intervention Type
Drug
Intervention Name(s)
Stalevo (levodopa/ carbidopa/ entacapone)
Other Intervention Name(s)
Stalevo
Intervention Description
150mg, 125 mg, 100mg, 75mg of levodopa q.i.d. in 3.5 h interval
Intervention Type
Drug
Intervention Name(s)
Sinemet (levodopa/carbidopa)
Other Intervention Name(s)
Sinemet
Intervention Description
150 or 100 mg levodopa q.i.d. in 3.5 hr interval
Primary Outcome Measure Information:
Title
To demonstrate that reduced Stalevo strengths 75 mg and 125 mg following initial 100 mg and 150 mg strengths, will not increase Cmax of levodopa compared to Stalevo or levodopa/carbidopa dosing using equal strengths during the day.
Time Frame
2-11 weeks
Secondary Outcome Measure Information:
Title
Cmin, AUCo-tau
Time Frame
each subject 3 PK days between 1-6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Written informed consent (IC) obtained.
Good general health ascertained by detailed medical history, and laboratory and physical examinations.
Finnish speaking males or females, 18-70 years of age inclusive.
Normal weight defined as body mass index (BMI) 18.5-30.0 kg/m2 (inclusive) (BMI = weight/height2).
Weight at least 50.0 kg.
Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems).
Exclusion Criteria:
Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator.
Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, contraceptives or hormone replacement therapy are allowed.
Intake of any medication that could affect the outcome of the study.
Any clinically significant abnormal laboratory value or physical finding (including electrocardiogram [ECG]) and vital signs) that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study, as judged by the investigator.
Orthostatic hypotension; systolic and diastolic BP and heart rate HR after 3 minutes in supine position and after 3 minutes of standing:
decrease of ≥ 20 mmHg for systolic BP
decrease of ≥ 10 mmHg for diastolic BP.
Strong tendency to motion sickness.
Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.
Pregnant or lactating females.
Females of childbearing potential if they are not using proper contraception (hormonal contraception, intrauterine device (IUD) or surgical sterilization, spermicidal foam/Vagitorie, condom on male partner). Double methods (mentioned above) of contraception is needed during the study. (Note: women of childbearing potential with no current sexual relationship can be included without contraception according to the judgement of the investigator).
Recent or current (suspected) drug abuse or positive result in the drug abuse test.
Recent or current alcohol abuse (regular drinking more than 21 units per week for males and more than 16 units per week for females [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 stay at the study centre.
Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from the use of caffeine containing beverages while at the study centre.
Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.
Administration of another investigational treatment 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimmo Ingman
Organizational Affiliation
Orion Corporation, Orion Pharma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phase I Unit, Orion Pharma
City
Espoo
ZIP/Postal Code
02101
Country
Finland
12. IPD Sharing Statement
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Levodopa Concentration Profile With Stalevo 75/125 mg
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