Parkinson's DiseasePhase 1NOCOFPK2NCT02554734
Pharmacokinetic Study in Healthy Volunteers
A Phase 1 study testing levodopa, carbidopa, ODM-104 and levodopa, carbidopa, entacapone in people with Parkinson's Disease, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
Phase I open, randomized cross-over pharmacokinetic study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- levodopa, carbidopa, ODM-104 and levodopa, carbidopa, entacapone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2015to Nov 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
- All sexes
- 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 and females 18-65 years of age
- Normal weight defined as body mass index (BMI) 19-30 kg/m2 (BMI=weight/height m2)
- Weight at least 55 kg
- Regular intestinal transit (no recent history of recurrent constipation, diarrhea, 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) 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, neurological or psychiatric disease or cancer (except local non-melanoma skin cancer) within the previous 2 years.
- Family history (parents, siblings) of clinically significant cardiac conduction disease.
- 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. Hormonal contraception and 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 ECG and vital signs) 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/she takes part in the study.
- Known hypersensitivity to the active substances or the excipients of the drugs.
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- Pregnant or lactating females.
- 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 bpm or > 90 bpm in the supine position after 10 min rest at the screening visit.
- At the screening visit:
- systolic BP < 90 mmHg or > 150 mmHg in the supine position after 10 min rest diastolic BP < 50 mmHg or > 90 mmHg in the supine position after 10 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 (males) or 16 units per week (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 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 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 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Levodopa After Repeated Doses of Carbidopa, ODM-104 and Levodopa: an Open, Randomised Study With Crossover Design in Healthy Males and Females
Phase I open, randomized cross-over pharmacokinetic study.
Read the detailed description
The purpose of this study is to investigate the pharmacokinetics of levodopa, carbidopa, 3-OMD and ODM-104 after repeated doses of levodopa, carbidopa and ODM-104: an open, randomized, multicenter study with crossover design in healthy males and females.
- Conditions
- Parkinson's Disease
- Being tested
- levodopa, carbidopa, ODM-104, levodopa, carbidopa, entacapone
- 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
levodopa, carbidopa, entacaponeDrug
Also called Stalevo
| Study group | Role | What they receive |
|---|---|---|
| Levodopa standard carbidopa | Experimental | Levodopa, carbidopa, ODM-104 Receives: Drug: levodopa, carbidopa, ODM-104 |
| Levodopa modified carbidopa | Experimental | Levodopa, carbidopa, ODM-104 Receives: Drug: levodopa, carbidopa, ODM-104 |
| Stalevo | Active comparator | Levodopa, carbidopa, entacapone Receives: Drug: levodopa, carbidopa, entacapone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levodopa Peak Plasma Concentration (Cmax) and fluctuation of levodopa Cmax/Cmin, tau
Explore the Cmax of levodopa and fluctuation of levodopa Cmax/Cmin, tau
Measured: Blood samples collected frequently on day 7 for 24 hours.
Secondary outcomes (8)
Carbidopa Peak Plasma Concentration (Cmax)
Explore Cmax of carbidopa
Measured: Blood samples collected frequently on day 7 for 24 hours.
3-OMD Peak Plasma Concentration (Cmax)
Explore Cmax of 3-OMD
Measured: Blood samples collected frequently on day 7 for 24 hours.
Levodopa Cmax, tau
Explore Cmax, tau of levodopa
Measured: Blood samples collected frequently on day 7 for 24 hours.
Levodopa Cmin, tau
Explore Cmin, tau of levodopa
Measured: Blood samples collected frequently on day 7 for 24 hours.
Levodopa Area under the plasma concentration versus time curve (AUC)
Explore AUC of levodopa
Measured: Blood samples collected frequently on day 7 for 24 hours.
Carbidopa Area under the plasma concentration versus time curve (AUC)
Explore AUC of carbidopa
Measured: Blood samples collected frequently on day 7 for 24 hours.
3-OMD Area under the plasma concentration versus time curve (AUC)
Explore AUC of 3-OMD
Measured: Blood samples collected frequently on day 7 for 24 hours.
Levodopa Peak-trough fluctuation (PTF)
Explore PTF of levodopa
Measured: Blood samples collected frequently on day 7 for 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2015
- Study completionNov 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
- 15 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, Clinical Research Services Turku CRST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554734
- Sponsor's protocol ID
- 3112003
- Acronym
- NOCOFPK2
- Status last verified
- Jan 2016
- First submitted
- 10 Jun 2015
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Levodopa After Repeated Doses of Carbidopa, ODM-104 and Levodopa: an Open, Randomised Study With Crossover Design in Healthy Males and Females
- ClinicalTrials.gov ID
- NCT02554734
- Acronym / sponsor ID
- NOCOFPK2 / 3112003
- Conditions
- Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Sep 2015 (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.
Phase I open, randomized cross-over pharmacokinetic study.
Detailed description
The purpose of this study is to investigate the pharmacokinetics of levodopa, carbidopa, 3-OMD and ODM-104 after repeated doses of levodopa, carbidopa and ODM-104: an open, randomized, multicenter study with crossover design in healthy males and females.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Levodopa standard carbidopa | Experimental | Drug: levodopa, carbidopa, ODM-104Levodopa, carbidopa, ODM-104 |
| Levodopa modified carbidopa | Experimental | Drug: levodopa, carbidopa, ODM-104Levodopa, carbidopa, ODM-104 |
| Stalevo | Active comparator | Drug: levodopa, carbidopa, entacaponeLevodopa, carbidopa, entacapone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- 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 and females 18-65 years of age
- Normal weight defined as body mass index (BMI) 19-30 kg/m2 (BMI=weight/height m2)
- Weight at least 55 kg
Key exclusion criteria (22 listed)
- 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.
- Family history (parents, siblings) of clinically significant cardiac conduction disease.
- 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. Hormonal contraception and 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 ECG and vital signs) 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/she takes part in 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 | Levodopa modified carbidopa, Levodopa standard carbidopa |
| levodopa, carbidopa, entacaponeAlso: Stalevo | Drug | Stalevo |
Primary outcome
Levodopa Peak Plasma Concentration (Cmax) and fluctuation of levodopa Cmax/Cmin, tau
Time frame: Blood samples collected frequently on day 7 for 24 hours.
Explore the Cmax of levodopa and fluctuation of levodopa Cmax/Cmin, tau
8 secondary outcomes
Carbidopa Peak Plasma Concentration (Cmax)
Time frame: Blood samples collected frequently on day 7 for 24 hours.
3-OMD Peak Plasma Concentration (Cmax)
Time frame: Blood samples collected frequently on day 7 for 24 hours.
Levodopa Cmax, tau
Time frame: Blood samples collected frequently on day 7 for 24 hours.
Levodopa Cmin, tau
Time frame: Blood samples collected frequently on day 7 for 24 hours.
Levodopa Area under the plasma concentration versus time curve (AUC)
Time frame: Blood samples collected frequently on day 7 for 24 hours.
Carbidopa Area under the plasma concentration versus time curve (AUC)
Time frame: Blood samples collected frequently on day 7 for 24 hours.
3-OMD Area under the plasma concentration versus time curve (AUC)
Time frame: Blood samples collected frequently on day 7 for 24 hours.
Levodopa Peak-trough fluctuation (PTF)
Time frame: Blood samples collected frequently on day 7 for 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 14 Jan 2016.
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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
Clinical Research Services Turku CRST
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 and levodopa, carbidopa, entacapone 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 22 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 14 Jan 2016. 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?
Levodopa Peak Plasma Concentration (Cmax) and fluctuation of levodopa Cmax/Cmin, tau (time frame: Blood samples collected frequently on day 7 for 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 14 Jan 2016.