Parkinson's DiseasePhase 1NOCOFNCT02312232
Pharmacokinetic Study in Healthy Males
A Phase 1 study testing levodopa, carbidopa, ODM-104 in people with Parkinson's Disease, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- levodopa, carbidopa, ODM-104
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2014to Feb 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Parkinson's Disease
- Being tested
- levodopa, carbidopa, ODM-104
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levodopa, carbidopa, ODM-104Drug
Also called Sinemet
| Study group | Role | What they receive |
|---|---|---|
| Levodopa formulation A | Experimental | Levodopa formulation A together with ODM-104 100 mg and carbidopa Receives: Drug: levodopa, carbidopa, ODM-104 |
| levodopa formulation B | Experimental | levodopa formulation B together with ODM-104 100 mg and carbidopa Receives: Drug: levodopa, carbidopa, ODM-104 |
| levodopa formulation C | Experimental | levodopa formulation C together with ODM-104 100 mg and carbidopa Receives: Drug: levodopa, carbidopa, ODM-104 |
| Sinemet IR 100/25 mg | Active comparator | Sinemet IR 100/25 mg together with ODM-104 100 mg Receives: Drug: levodopa, carbidopa, ODM-104 |
| Half Sinemet CR 100/25 mg | Active comparator | Half Sinemet CR 100/25 mg together with ODM-104 100 mg Receives: Drug: levodopa, carbidopa, ODM-104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (Cmax) of levodopa
Peak Plasma Concentration (Cmax)
Measured: 24 hours
Secondary outcomes (1)
Pharmacokinetics (Cmax) of carbidopa, 3-OMD and ODM-104
Peak Plasma Concentration (Cmax)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mika Scheinin, MD, Principal investigator, CRST Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312232
- Sponsor's protocol ID
- 3112002
- Acronym
- NOCOF
- Status last verified
- Feb 2015
- First submitted
- 2 Dec 2014
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02312232
- Acronym / sponsor ID
- NOCOF / 3112002
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Levodopa formulation A | Experimental | Drug: levodopa, carbidopa, ODM-104Levodopa formulation A together with ODM-104 100 mg and carbidopa |
| levodopa formulation B | Experimental | Drug: levodopa, carbidopa, ODM-104levodopa formulation B together with ODM-104 100 mg and carbidopa |
| levodopa formulation C | Experimental | Drug: levodopa, carbidopa, ODM-104levodopa formulation C together with ODM-104 100 mg and carbidopa |
| Sinemet IR 100/25 mg | Active comparator | Drug: levodopa, carbidopa, ODM-104Sinemet IR 100/25 mg together with ODM-104 100 mg |
| Half Sinemet CR 100/25 mg | Active comparator | Drug: levodopa, carbidopa, ODM-104Half Sinemet CR 100/25 mg together with ODM-104 100 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levodopa, carbidopa, ODM-104Also: Sinemet | Drug | Half Sinemet CR 100/25 mg, Levodopa formulation A, Sinemet IR 100/25 mg, levodopa formulation B, levodopa formulation C |
Primary outcome
Pharmacokinetics (Cmax) of levodopa
Time frame: 24 hours
Peak Plasma Concentration (Cmax)
1 secondary outcome
Pharmacokinetics (Cmax) of carbidopa, 3-OMD and ODM-104
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mika Scheinin, MD principal investigator
CRST Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing levodopa, carbidopa, ODM-104 in people with Parkinson's Disease, run by Orion Corporation, Orion Pharma at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (Cmax) of levodopa (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.