Parkinson DiseasePhase 1NCT03140956
Pharmacokinetic of Levodopa Study in Healthy Males
A Phase 1 study testing Levodopa, carbidopa, ODM-104 in people with Parkinson Disease, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial 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. 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 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
- 19 Apr 2017to 3 Aug 2017
- 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.
- 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.
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.
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of Levodopa After Repeated Doses of Different Pellet Formulations; An Open, Randomized Study With Crossover Design in Healthy Male Subjects
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.
- Conditions
- Parkinson 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
Crossover design. Study treatments will be administered in randomized order 4 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Levodopa formulation D | Experimental | Levodopa formulation D Receives: Drug: Levodopa, carbidopa, ODM-104 |
| Levodopa formulation E | Experimental | Levodopa formulation E Receives: Drug: Levodopa, carbidopa, ODM-104 |
| Levodopa formulation F | Experimental | Levodopa formulation F Receives: Drug: Levodopa, carbidopa, ODM-104 |
| Sinemet IR 100/25mg | Active comparator | Sinemet IR 100/25MG Receives: Drug: Levodopa, carbidopa, ODM-104 |
| Sinemet CR 100/25mg | Active comparator | Sinemet IR 100/25MG Receives: Drug: Levodopa, carbidopa, ODM-104 |
| ODM-104 100mg | Experimental | ODM-104 100MG Receives: Drug: Levodopa, carbidopa, ODM-104 |
| Carbidopa 20mg | Active comparator | Carbidopa 20MG Receives: Drug: Levodopa, carbidopa, ODM-104 |
| Carbidopa 65mg | Active comparator | Carbidopa 65MG 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start19 Apr 2017
- Primary completion3 Jul 2017
- Study completion3 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140956
- Sponsor's protocol ID
- 3112006
- Status last verified
- Sep 2017
- First submitted
- 12 Apr 2017
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Levodopa After Repeated Doses of Different Pellet Formulations; An Open, Randomized Study With Crossover Design in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03140956
- Acronym / sponsor ID
- 3112006
- Conditions
- Parkinson 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
- 19 Apr 2017 (actual)
- Primary completion
- 3 Jul 2017 (actual)
- Study completion
- 3 Aug 2017 (actual)
- First posted
- 4 May 2017 (actual)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Levodopa formulation D | Experimental | Drug: Levodopa, carbidopa, ODM-104Levodopa formulation D |
| Levodopa formulation E | Experimental | Drug: Levodopa, carbidopa, ODM-104Levodopa formulation E |
| Levodopa formulation F | Experimental | Drug: Levodopa, carbidopa, ODM-104Levodopa formulation F |
| Sinemet IR 100/25mg | Active comparator | Drug: Levodopa, carbidopa, ODM-104Sinemet IR 100/25MG |
| Sinemet CR 100/25mg | Active comparator | Drug: Levodopa, carbidopa, ODM-104Sinemet IR 100/25MG |
| ODM-104 100mg | Experimental | Drug: Levodopa, carbidopa, ODM-104ODM-104 100MG |
| Carbidopa 20mg | Active comparator | Drug: Levodopa, carbidopa, ODM-104Carbidopa 20MG |
| Carbidopa 65mg | Active comparator | Drug: Levodopa, carbidopa, ODM-104Carbidopa 65MG |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (18 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.
- 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.
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: SinemetCrossover design. Study treatments will be administered in randomized order 4 times a day. | Drug | Carbidopa 20mg, Carbidopa 65mg, Levodopa formulation D, Levodopa formulation E, Levodopa formulation F, ODM-104 100mg, Sinemet CR 100/25mg, Sinemet IR 100/25mg |
Primary outcome
Pharmacokinetics (Cmax) of levodopa
Time frame: 24 hours
Peak Plasma Concentration (Cmax)
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 26 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 6 inclusion and 18 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 26 Sep 2017. 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 26 Sep 2017.