Healthy VolunteersPhase 1COMDOS1NCT03055936
Dose-finding Pharmacokinetic Study in Healthy Males
A Phase 1 study testing Levodopa, Carbidopa and ODM-104 in people with Healthy Volunteers, run by Orion Corporation, Orion Pharma at 1 site in Germany.
Trial summary
This is a phase I PK study in healthy males. 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
- Healthy Volunteers
- What is being tested?
- Levodopa, Carbidopa and ODM-104
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- 21 Feb 2017to 9 Jun 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
- Males between 18-65 years of age inclusive at screening.
- Body mass index (BMI) between 19-30 kg/m2 (BMI = weight/height2) inclusive at screening.
- Weight at least 55 kg inclusive at screening.
- Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems, and no history of major gastrointestinal surgery).
- Subject with a partner of childbearing potential agrees to use adequate contraception from the first dose of study treatment until 90 days after the last dose of study treatment. Adequate methods of contraception include: Hormonal contraceptives, barrier methods (condom, diaphragm, cervical cap, etc.) in combination with a spermicide, intrauterine device and sexual abstinence.
- Subject agrees to not donate sperm from the first dose of study treatment until 90 days after the last dose of study treatment.
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 < 50 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 < 100 mmHg or > 140 mmHg in the supine position after 5 min rest
- diastolic BP < 50 mmHg or > 90 mmHg in the supine position after 5 min rest.
- Creatinine > 1.5 x upper limit of normal (ULN) and alanine aminotransferase or aspartate aminotransferase >1.25 x ULN at screening.
- 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 for 48 h before the first dose in each period until collection of the 24 h PK sample in the morning of day 8.
- 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 (> 500 ml) within 90 days before the first study treatment administration.
- Participation in another investigational drug study or administration of another investigational drug within 60 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: A Dose-finding Study for Levodopa, Carbidopa and ODM-104 Test Formulations After Repeated Administration in Healthy Males
This is a phase I PK study in healthy males.
Read the detailed description
This is a phase I, open, repeated dose, randomised PK study in healthy males. The study will consist of 4 parallel groups (Groups 1-4). All groups will have a crossover design with 4 treatment periods, each lasting for 7 days.
- Conditions
- Healthy Volunteers
- Being tested
- Levodopa, Carbidopa, ODM-104
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevodopaDrug
Also called Sinemet
Levodopa 50 mg or 100 mg or 150 mg
CarbidopaDrug
Carbidopa 12.5 mg or 25 mg or 65 mg
ODM-104Drug
ODM-104 50 mg or 100 mg
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | levodopa 50 mg, carbidopa 12.5 mg Receives: Drug: Levodopa; Drug: Carbidopa |
| B1 | Experimental | levodopa 50 mg, carbidopa 65 mg Receives: Drug: Levodopa; Drug: Carbidopa |
| C1 | Experimental | levodopa 50 mg, carbidopa 65 mg, ODM-104 50 mg Receives: Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104 |
| D1 | Experimental | levodopa 50 mg, carbidopa 65 mg, ODM-104 100 mg A4 ; B4 l; C4 ; D4 levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg Receives: Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104 |
| A2 | Experimental | levodopa 100 mg, carbidopa 25 mg Receives: Drug: Levodopa; Drug: Carbidopa |
| B2 | Experimental | levodopa 100 mg, carbidopa 65 mg Receives: Drug: Levodopa; Drug: Carbidopa |
| C2 | Experimental | levodopa 100 mg, carbidopa 65 mg, ODM-104 50 mg Receives: Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104 |
| D2 | Experimental | levodopa 100 mg, carbidopa 37,5 mg Receives: Drug: Levodopa; Drug: Carbidopa |
| A3 | Experimental | levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg Receives: Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104 |
| B3 | Experimental | levodopa 150 mg, carbidopa 65 mg Receives: Drug: Levodopa; Drug: Carbidopa |
| C3 | Experimental | levodopa 150 mg, carbidopa 65 mg, ODM-104 50 mg Receives: Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104 |
| D3 | Experimental | levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg Receives: Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104 |
| A4 | Experimental | levodopa IR 100 mg (Sinemet), carbidopa 25 mg Receives: Drug: Levodopa; Drug: Carbidopa |
| B4 | Experimental | levodopa 100 mg, carbidopa 65 mg Receives: Drug: Levodopa; Drug: Carbidopa |
| C4 | Experimental | levodopa 100 mg, carbidopa 25 mg, ODM-104 100 mg Receives: Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104 |
| D4 | Experimental | levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg Receives: Drug: Levodopa; Drug: Carbidopa; Drug: ODM-104 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24) Time 0 to the 24 h PK Sample (AUC0-24)
Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24)
Measured: During 24 hours
Secondary outcomes (2)
Fluctuation of Levodopa Cmax/Cmin, Tau
Explore fluctuation of levodopa Cmax/Cmin, tau. Figures given are per performed statistical analysis.
Measured: 16 hours
Levodopa Peak Plasma Concentration (Cmax)
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 posted16 Feb 2017
- Study start21 Feb 2017
- Primary completion9 Jun 2017
- Study completion9 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Denis Strugala, DR.med., Principal investigator, Nuvisan GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055936
- Sponsor's protocol ID
- 3112005
- Acronym
- COMDOS1
- Status last verified
- May 2021
- First submitted
- 20 Jan 2017
- Last updated
- 27 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-finding Study for Levodopa, Carbidopa and ODM-104 Test Formulations After Repeated Administration in Healthy Males
- ClinicalTrials.gov ID
- NCT03055936
- Acronym / sponsor ID
- COMDOS1 / 3112005
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 9 Jun 2017 (actual)
- Study completion
- 9 Jun 2017 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Posted 27 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I PK study in healthy males.
Detailed description
This is a phase I, open, repeated dose, randomised PK study in healthy males. The study will consist of 4 parallel groups (Groups 1-4). All groups will have a crossover design with 4 treatment periods, each lasting for 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: Levodopa, Drug: Carbidopalevodopa 50 mg, carbidopa 12.5 mg |
| B1 | Experimental | Drug: Levodopa, Drug: Carbidopalevodopa 50 mg, carbidopa 65 mg |
| C1 | Experimental | Drug: Levodopa, Drug: Carbidopa, Drug: ODM-104levodopa 50 mg, carbidopa 65 mg, ODM-104 50 mg |
| D1 | Experimental | Drug: Levodopa, Drug: Carbidopa, Drug: ODM-104levodopa 50 mg, carbidopa 65 mg, ODM-104 100 mg A4 ; B4 l; C4 ; D4 levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg |
| A2 | Experimental | Drug: Levodopa, Drug: Carbidopalevodopa 100 mg, carbidopa 25 mg |
| B2 | Experimental | Drug: Levodopa, Drug: Carbidopalevodopa 100 mg, carbidopa 65 mg |
| C2 | Experimental | Drug: Levodopa, Drug: Carbidopa, Drug: ODM-104levodopa 100 mg, carbidopa 65 mg, ODM-104 50 mg |
| D2 | Experimental | Drug: Levodopa, Drug: Carbidopalevodopa 100 mg, carbidopa 37,5 mg |
| A3 | Experimental | Drug: Levodopa, Drug: Carbidopa, Drug: ODM-104levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg |
| B3 | Experimental | Drug: Levodopa, Drug: Carbidopalevodopa 150 mg, carbidopa 65 mg |
| C3 | Experimental | Drug: Levodopa, Drug: Carbidopa, Drug: ODM-104levodopa 150 mg, carbidopa 65 mg, ODM-104 50 mg |
| D3 | Experimental | Drug: Levodopa, Drug: Carbidopa, Drug: ODM-104levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg |
| A4 | Experimental | Drug: Levodopa, Drug: Carbidopalevodopa IR 100 mg (Sinemet), carbidopa 25 mg |
| B4 | Experimental | Drug: Levodopa, Drug: Carbidopalevodopa 100 mg, carbidopa 65 mg |
| C4 | Experimental | Drug: Levodopa, Drug: Carbidopa, Drug: ODM-104levodopa 100 mg, carbidopa 25 mg, ODM-104 100 mg |
| D4 | Experimental | Drug: Levodopa, Drug: Carbidopa, Drug: ODM-104levodopa 100 mg, carbidopa 65 mg, 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 (8 listed)
- Written informed consent (IC) obtained.
- Good general health ascertained by detailed medical history and physical examinations.
- Males between 18-65 years of age inclusive at screening.
- Body mass index (BMI) between 19-30 kg/m2 (BMI = weight/height2) inclusive at screening.
- Weight at least 55 kg inclusive at screening.
Key exclusion criteria (21 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 |
|---|---|---|
| LevodopaAlso: SinemetLevodopa 50 mg or 100 mg or 150 mg | Drug | A1, A2, A3, A4, B1, B2, B3, B4, C1, C2, C3, C4, D1, D2, D3, D4 |
| CarbidopaCarbidopa 12.5 mg or 25 mg or 65 mg | Drug | A1, A2, A3, A4, B1, B2, B3, B4, C1, C2, C3, C4, D1, D2, D3, D4 |
| ODM-104ODM-104 50 mg or 100 mg | Drug | A3, C1, C2, C3, C4, D1, D3, D4 |
Primary outcome
Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24) Time 0 to the 24 h PK Sample (AUC0-24)
Time frame: During 24 hours
Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24)
2 secondary outcomes
Fluctuation of Levodopa Cmax/Cmin, Tau
Time frame: 16 hours
Levodopa Peak Plasma Concentration (Cmax)
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Denis Strugala, DR.med. principal investigator
Nuvisan GmbH
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 and ODM-104 in people with Healthy Volunteers, run by Orion Corporation, Orion Pharma at 1 site in Germany.
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 8 inclusion and 21 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 27 May 2021. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 27 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24) Time 0 to the 24 h PK Sample (AUC0-24) (time frame: During 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 27 May 2021.