HealthyPhase 1KIPEVNCT03240445
Impact of Changing the Dosing Regimen on the PK Profile of ODM-203
A Phase 1 study testing ODM-203 (Period 1), ODM-203 (Period 2) and ODM-203 (Periods 3-6) in people with Healthy, run by Orion Corporation, Orion Pharma at 1 site in United Kingdom.
Trial summary
This Phase I study in healthy male volunteers will evaluate the impact of the effect of food on the pharmacokinetic profile of ODM-203. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ODM-203 (Period 1), ODM-203 (Period 2) and ODM-203 (Periods 3-6)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Aug 2017to 23 Oct 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Able to speak, write and understand English
- Body mass index of 18.0-32.0
- Weight 55-95 kg
- Adequate method of contraception
- Good state of health
Who cannot join
- Receipt of IMP in a clinical research study or donation/loss of >400ml blood within previous 3 months or previously enrolled in this study
- History of drug or alcohol abuse or positive drugs of abuse test or regular alcohol consumption or current smoker/user of nicotine replacement products
- Positive drugs of abuse test
- Positive hepatitis B, hepatitis C or HIV results
- Donation/loss of >400ml blood within previous 3 months
- Poor compliance or inability to follow protocol requirements/instructions/restrictions.
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- Vulnerable subjects
- Evidence of clinically relevant disease of any body system including relevant psychiatric disorders or conditions requiring regular concomitant medication
- History of significant hypersensitivity, anaphylaxis, intolerance to drugs/food
- Propensity to get headaches when refraining from caffeine containing beverages
- Any abnormal laboratory value, vital signs, ECG parameter or physical examination interfering with the test results or causing a health risk for the subject or failure to satisfy the investigator of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Part-randomised, Single Centre, Single Dose, Crossover,Phase I Study to Investigate the Impact of Changes to the Dosing Regimen on the Pharmacokinetic Profile of ODM-203 in Healthy Male Volunteers
This Phase I study in healthy male volunteers will evaluate the impact of the effect of food on the pharmacokinetic profile of ODM-203.
Read the detailed description
This study will be a single dose part randomised cross over study with up to 6 study periods. ODM-203 may be dosed using a variety of different conditions with respect to food depending on emerging data. The impact of changing the presentation of ODM-203 may also be assessed to determine the PK of alternative formulations and identify appropriate drug formulations for further development.
- Conditions
- Healthy
- Being tested
- ODM-203 (Period 1), ODM-203 (Period 2), ODM-203 (Periods 3-6)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM-203 (Period 1)Drug
ODM-203 400mg as tablets taken 30 minutes after food
ODM-203 (Period 2)Drug
ODM-203 400mg as tablets taken 1 hour before a light breakfast
ODM-203 (Periods 3-6)Drug
ODM- 203 400mg as tablets for oral administration or 400mg as oral dispersion either before/after food
| Study group | Role | What they receive |
|---|---|---|
| Period 1 | Experimental | ODM-203 dosed after food Receives: Drug: ODM-203 (Period 1) |
| Period 2 | Experimental | ODM-203 dosed before food Receives: Drug: ODM-203 (Period 2) |
| Periods 3-6 | Experimental | ODM-203 dosed as a tablet or dispersion Receives: Drug: ODM-203 (Periods 3-6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration curve(AUC) ODM-203 in the presence and absence of food
Area under the plasma concentration curve (AUC) will be measured to investigate the pharmacokinetic profile of ODM-203 in the presence and absence of food
Measured: 0 to 72 hours
Secondary outcomes (2)
Number of adverse events
Number of adverse events counts
Measured: From the date of informed consent to the date of the end of study estimated to be up to 17 weeks
Area under the plasma concentration curve(AUC) ORM-21444 in the presence and absence of food
Area under the plasma concentration curve (AUC) will be measured to investigate the pharmacokinetic profile of ORM-21444 in the presence and absence of food
Measured: 0 to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start24 Aug 2017
- Primary completion23 Oct 2017
- Study completion23 Oct 2017
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Responsible party
- Sponsor
- Investigators
- Clare Preskey, BSc, Study director, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240445
- Sponsor's protocol ID
- 3113004
- Acronym
- KIPEV
- Status last verified
- May 2019
- First submitted
- 26 Jul 2017
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Part-randomised, Single Centre, Single Dose, Crossover,Phase I Study to Investigate the Impact of Changes to the Dosing Regimen on the Pharmacokinetic Profile of ODM-203 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03240445
- Acronym / sponsor ID
- KIPEV / 3113004
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 23 Oct 2017 (actual)
- First posted
- 7 Aug 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.
This Phase I study in healthy male volunteers will evaluate the impact of the effect of food on the pharmacokinetic profile of ODM-203.
Detailed description
This study will be a single dose part randomised cross over study with up to 6 study periods. ODM-203 may be dosed using a variety of different conditions with respect to food depending on emerging data. The impact of changing the presentation of ODM-203 may also be assessed to determine the PK of alternative formulations and identify appropriate drug formulations for further development.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Period 1 | Experimental | Drug: ODM-203 (Period 1)ODM-203 dosed after food |
| Period 2 | Experimental | Drug: ODM-203 (Period 2)ODM-203 dosed before food |
| Periods 3-6 | Experimental | Drug: ODM-203 (Periods 3-6)ODM-203 dosed as a tablet or dispersion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent
- Able to speak, write and understand English
- Body mass index of 18.0-32.0
- Weight 55-95 kg
- Adequate method of contraception
Key exclusion criteria (11 listed)
- Receipt of IMP in a clinical research study or donation/loss of >400ml blood within previous 3 months or previously enrolled in this study
- History of drug or alcohol abuse or positive drugs of abuse test or regular alcohol consumption or current smoker/user of nicotine replacement products
- Positive drugs of abuse test
- Positive hepatitis B, hepatitis C or HIV results
- Donation/loss of >400ml blood within previous 3 months
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-203 (Period 1)ODM-203 400mg as tablets taken 30 minutes after food | Drug | Period 1 |
| ODM-203 (Period 2)ODM-203 400mg as tablets taken 1 hour before a light breakfast | Drug | Period 2 |
| ODM-203 (Periods 3-6)ODM- 203 400mg as tablets for oral administration or 400mg as oral dispersion either before/after food | Drug | Periods 3-6 |
Primary outcome
Area under the plasma concentration curve(AUC) ODM-203 in the presence and absence of food
Time frame: 0 to 72 hours
Area under the plasma concentration curve (AUC) will be measured to investigate the pharmacokinetic profile of ODM-203 in the presence and absence of food
2 secondary outcomes
Number of adverse events
Time frame: From the date of informed consent to the date of the end of study estimated to be up to 17 weeks
Area under the plasma concentration curve(AUC) ORM-21444 in the presence and absence of food
Time frame: 0 to 72 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 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Clare Preskey, BSc study director
Quotient Clinical
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-203 (Period 1), ODM-203 (Period 2) and ODM-203 (Periods 3-6) in people with Healthy, run by Orion Corporation, Orion Pharma at 1 site in United Kingdom.
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 11 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 May 2019. 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 United Kingdom. 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?
Area under the plasma concentration curve(AUC) ODM-203 in the presence and absence of food (time frame: 0 to 72 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 May 2019.