HealthyPhase 1NOCIFIMNCT01840423
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers
A Phase 1 study testing ODM-104, Entacapone and levodopa/carbidopa in people with Healthy, run by Orion Corporation, Orion Pharma at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-104 when given to healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ODM-104, Entacapone and levodopa/carbidopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteGermany
- Study dates
- May 2013to Dec 2014
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects aged between 18 and 45 years
- BMI 18-30 kg/m2
- Weight 55-95kg
- Written informed consent
- Good General Health
Who cannot join
- Vulnerable subjects
- Veins unsuitable for repeated venipuncture
- Evidence of clinically significant cardiovascular, renal, hepatic, hematological, Gi, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disorder
- History of or positive test for drug abuse
- Any condition requiring regular concomitant medication
- Blood donation or significant loss of blood within 2 months prior to screening
Show all 12Show fewer
- Abnormal 12 lead ECG finding of clinical relevance
- Heart rate (HR) <50bpm or >90bpm after 10 minutes in a supine position
- Systolic blood pressure <90mmHg or >140mmHg after 10 minutes in a supine position
- Diastolic blood pressure <50mmHg or >90mmHg after 10 minutes in a supine position
- Abnormal 24 hour Holter recording of clinical relevance at screening
- Any abnormal laboratory value, vital signs or physical examination causing a health risk to the volunteer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Repeated Escalating Doses of ODM-104: a Randomised, Double-blind, Placebo- and Entacapone-controlled Single Centre First-in-man Study in Healthy Volunteers.
The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-104 when given to healthy male volunteers.
Read the detailed description
The study is divided into two parts. Part one is a crossover study where healthy volunteers will receive two doses of ODM-104 and one dose of placebo. Part II of the study is a multiple ascending dose parallel group study where healthy volunteers will receive ODM-104 three times daily for seven days. Healthy volunteers taking part in Part II of the study will also receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in addition to ODM-104 on day 9. The study will also look at the pharmacokinetic(how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-104.
- Conditions
- Healthy
- Being tested
- ODM-104, Placebo, Entacapone, levodopa/carbidopa
- Keywords
- First in man study, Volunteer study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM-104Drug
ODM-104
PlaceboDrug
Placebo
EntacaponeDrug
entacapone + levodopa/carbidopa
levodopa/carbidopaDrug
entacapone + levodopa/carbidopa
| Study group | Role | What they receive |
|---|---|---|
| ODM-104 | Experimental | Oral capsules dosage 10-800mg once daily for one day or three times daily for 7 days Receives: Drug: ODM-104 |
| Placebo | Placebo comparator | Oral capsules given once daily for one day or three times daily for 7 days Receives: Drug: Placebo |
| entacapone + levodopa/carbidopa | Active comparator | entacapone: oral tablet 200mg given four times daily for one day; levodopa/carbidopa: oral tablet 100/25mg given four times daily for one day Receives: Drug: Entacapone; Drug: levodopa/carbidopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythrocyte Catechol-O-methyltransferase (COMT) inhibition.
Maximal COMT inhibition and area under the COMT inhibition curve (AUCC)
Measured: 0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose
Secondary outcomes (1)
Area under the plasma concentration curve (AUC)
AUC under the plasma concentration curve
Measured: 0, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2, 4, 6, 10, 16, 24h post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rainard Fuhr, MD, Principal investigator, Parexelangela ruck, PhD, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840423
- Sponsor's protocol ID
- 3112001
- Acronym
- NOCIFIM
- Status last verified
- Mar 2015
- First submitted
- 23 Apr 2013
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Repeated Escalating Doses of ODM-104: a Randomised, Double-blind, Placebo- and Entacapone-controlled Single Centre First-in-man Study in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01840423
- Acronym / sponsor ID
- NOCIFIM / 3112001
- Conditions
- Healthy
- Keywords
- First in man study, Volunteer study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Apr 2013 (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 evaluate the safety and tolerability of escalating doses of ODM-104 when given to healthy male volunteers.
Detailed description
The study is divided into two parts. Part one is a crossover study where healthy volunteers will receive two doses of ODM-104 and one dose of placebo. Part II of the study is a multiple ascending dose parallel group study where healthy volunteers will receive ODM-104 three times daily for seven days. Healthy volunteers taking part in Part II of the study will also receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in addition to ODM-104 on day 9. The study will also look at the pharmacokinetic(how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-104.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ODM-104 | Experimental | Drug: ODM-104Oral capsules dosage 10-800mg once daily for one day or three times daily for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboOral capsules given once daily for one day or three times daily for 7 days |
| entacapone + levodopa/carbidopa | Active comparator | Drug: Entacapone, Drug: levodopa/carbidopaentacapone: oral tablet 200mg given four times daily for one day; levodopa/carbidopa: oral tablet 100/25mg given four times daily for one day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male subjects aged between 18 and 45 years
- BMI 18-30 kg/m2
- Weight 55-95kg
- Written informed consent
- Good General Health
Key exclusion criteria (12 listed)
- Vulnerable subjects
- Veins unsuitable for repeated venipuncture
- Evidence of clinically significant cardiovascular, renal, hepatic, hematological, Gi, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disorder
- History of or positive test for drug abuse
- Any condition requiring regular concomitant medication
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 |
|---|---|---|
| ODM-104ODM-104 | Drug | ODM-104 |
| PlaceboPlacebo | Drug | Placebo |
| Entacaponeentacapone + levodopa/carbidopa | Drug | entacapone + levodopa/carbidopa |
| levodopa/carbidopaentacapone + levodopa/carbidopa | Drug | entacapone + levodopa/carbidopa |
Primary outcome
Erythrocyte Catechol-O-methyltransferase (COMT) inhibition.
Time frame: 0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose
Maximal COMT inhibition and area under the COMT inhibition curve (AUCC)
1 secondary outcome
Area under the plasma concentration curve (AUC)
Time frame: 0, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2, 4, 6, 10, 16, 24h post dose
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 1 Apr 2015.
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Healthy Volunteer
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.
Rainard Fuhr, MD principal investigator
Parexel
angela ruck, PhD study director
Orion Corporation, Orion Pharma
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 ODM-104, Entacapone and levodopa/carbidopa in people with Healthy, 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 5 inclusion and 12 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 1 Apr 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 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. Some participants in this study may receive a placebo. 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?
Erythrocyte Catechol-O-methyltransferase (COMT) inhibition. (time frame: 0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose). 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 1 Apr 2015; AzTrials last refreshed its copy on 8 Nov 2026.