HealthyPhase 1Nebula PK 1NCT02319057
Pharmacokinetic Study of Single Doses of ORM-12741
A Phase 1 study testing ORM-12741 MR A, ORM-12741 IR and ORM-12741 MR B in people with Healthy, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
The purpose of this study is to evaluate ORM-12741 concentrations in the blood after different study drug formulations Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ORM-12741 MR A, ORM-12741 IR and ORM-12741 MR B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2014to Feb 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 examination.
- Females and males between 18 and 65 years of age (inclusive).
- Body mass index (BMI) between 18-30 kg/m2 (inclusive, BMI = weight/height2).
- Weight of 50-100 kg (inclusive).
- Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems).
Who cannot join
- Predicted poor compliance or inability to communicate well with the investigator or the study centre personnel.
- Veins unsuitable for repeated venipuncture or cannulation.
- Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator.
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. Hormonal contraception and hormone replacement therapy are allowed.
- Susceptibility to severe allergic reactions.
- Intake of any medication that could affect the outcome of the study, within 2 weeks prior to the first study treatment administration or less than 5 times the half-life of the medication. Possible enzyme inducing drugs will be discussed case-by-case with the sponsor.
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- Regular consumption of more than 21 units of alcohol per week for males and 16 units per week for females (1 unit = 4 cl spirits, about 13 g of alcohol).
- Current use of nicotine-containing products more than 5 cigarettes or equivalent/day.
- Inability to refrain from using nicotine-containing products during the stay at the study centre.
- Inability to refrain from consuming caffeine-containing beverages during the stay at the study centre, e.g. propensity to develop headaches when refraining from caffeine-containing beverages.
- Blood donation or loss of significant amount of blood within 3 months prior to the first study treatment administration.
- Any clinically significant 12-lead electrocardiogram (ECG) abnormality after a 10-minute rest in supine position at the screening visit, as judged by the investigator. For example:
- QTc (calculated with the Bazett's formula) > 470 msec for females and 450 msec for men.
- HR < 45 beats/minute or > 100 beats/minute after a 10-minute rest in supine position at the screening visit.
- At the screening visit systolic blood pressure (BP) < 90 mmHg or > 150 mmHg after a 10- minute rest in supine position, diastolic BP < 50 mmHg or > 90 mmHg after a 10-minute rest in supine position, or symptomatic orthostatic hypotension, or
- decrease of ≥ 20 mmHg of systolic BP or
- decrease of ≥ 10 mmHg of diastolic BP after 3 minutes in standing position.
- Any abnormal value in laboratory tests, or vital signs, or physical examination finding, which in the opinion of the investigator could interfere with the interpretation of the test results or cause a health risk for the subject if he takes part in the study.
- History of drug abuse or positive result in drug abuse test.
- Positive serology to human immunodeficiency virus antibodies (HIVAgAb), hepatitis C virus antibodies (HCVAb) or hepatitis B surface antigen (HBsAg).
- Females of childbearing potential if they are not using proper contraception (hormonal contraception, intrauterine device [IUD] or surgical sterilization, spermicidal foam in conjunction with condom on male partner) during the study. Use of oral/hormonal contraception alone is not acceptable. (Note: women of childbearing potential with no current heterosexual relationship can be included without contraception according to the judgement of the investigator).
- Any other condition that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health risk for the study subject.
- Participation in a clinical drug study within 3 months prior to the first study treatment administration of this study or earlier participation in a clinical study with ORM-12741.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Study of Modified Release Formulations and an Immediate Release Formulation of ORM-12741 After Single Oral Doses
The purpose of this study is to evaluate ORM-12741 concentrations in the blood after different study drug formulations
Read the detailed description
The purpose of this study is to evaluate the pharmacokinetics and safety of single doses of modified release formulations and a immediate release formulation of ORM-12741
- Conditions
- Healthy
- Being tested
- ORM-12741 MR A, ORM-12741 IR, ORM-12741 MR B
- Keywords
- Healthy volunteer study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORM-12741 MR ADrug
Modified release formulation of ORM-12741
ORM-12741 IRDrug
Immediate release formulation of ORM-12741
ORM-12741 MR BDrug
Modified release formulation of ORM-12741
| Study group | Role | What they receive |
|---|---|---|
| Panel 1 | Experimental | Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these Receives: Drug: ORM-12741 MR A; Drug: ORM-12741 IR; Drug: ORM-12741 MR B |
| Panel 2 | Experimental | Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these Receives: Drug: ORM-12741 MR A; Drug: ORM-12741 IR; Drug: ORM-12741 MR B |
| Panel 3 | Experimental | Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these Receives: Drug: ORM-12741 MR A; Drug: ORM-12741 IR; Drug: ORM-12741 MR B |
| Panel 4 | Experimental | Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these Receives: Drug: ORM-12741 MR A; Drug: ORM-12741 IR; Drug: ORM-12741 MR B |
| Panel 5 | Experimental | Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these Receives: Drug: ORM-12741 MR A; Drug: ORM-12741 IR; Drug: ORM-12741 MR B |
| Panel 6 | Experimental | Adaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these Receives: Drug: ORM-12741 MR A; Drug: ORM-12741 IR; Drug: ORM-12741 MR B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Explore the PK profile (e.g. Cmax, tmax, AUC, t1/2) and determine protein binding
Measured: Blood samples collected frequently on day 1 and once or twice a day for 4 days
Secondary outcomes (1)
Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values
adverse events, vital signs, ECG, safety laboratory values
Measured: 24 hours per period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT02319057
- Sponsor's protocol ID
- 3098011
- Other IDs
- 2014-000193-19, 2014
- Acronym
- Nebula PK 1
- Status last verified
- May 2015
- First submitted
- 6 Oct 2014
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Modified Release Formulations and an Immediate Release Formulation of ORM-12741 After Single Oral Doses
- ClinicalTrials.gov ID
- NCT02319057
- Acronym / sponsor ID
- Nebula PK 1 / 3098011
- Conditions
- Healthy
- Keywords
- Healthy volunteer study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 18 Dec 2014 (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 ORM-12741 concentrations in the blood after different study drug formulations
Detailed description
The purpose of this study is to evaluate the pharmacokinetics and safety of single doses of modified release formulations and a immediate release formulation of ORM-12741
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Panel 1 | Experimental | Drug: ORM-12741 MR A, Drug: ORM-12741 IR, Drug: ORM-12741 MR BAdaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these |
| Panel 2 | Experimental | Drug: ORM-12741 MR A, Drug: ORM-12741 IR, Drug: ORM-12741 MR BAdaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these |
| Panel 3 | Experimental | Drug: ORM-12741 MR A, Drug: ORM-12741 IR, Drug: ORM-12741 MR BAdaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these |
| Panel 4 | Experimental | Drug: ORM-12741 MR A, Drug: ORM-12741 IR, Drug: ORM-12741 MR BAdaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these |
| Panel 5 | Experimental | Drug: ORM-12741 MR A, Drug: ORM-12741 IR, Drug: ORM-12741 MR BAdaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these |
| Panel 6 | Experimental | Drug: ORM-12741 MR A, Drug: ORM-12741 IR, Drug: ORM-12741 MR BAdaptive design: Each subject will receive 1-4 single doses of ORM-12741 including various dose levels of ORM-12741 MR A, ORM-12741 MR B, ORM-12741 IR or combination of these |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent (IC) obtained.
- Good general health ascertained by detailed medical history and physical examination.
- Females and males between 18 and 65 years of age (inclusive).
- Body mass index (BMI) between 18-30 kg/m2 (inclusive, BMI = weight/height2).
- Weight of 50-100 kg (inclusive).
Key exclusion criteria (23 listed)
- Predicted poor compliance or inability to communicate well with the investigator or the study centre personnel.
- Veins unsuitable for repeated venipuncture or cannulation.
- Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator.
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. Hormonal contraception and hormone replacement therapy are allowed.
- Susceptibility to severe allergic reactions.
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 |
|---|---|---|
| ORM-12741 MR AModified release formulation of ORM-12741 | Drug | Panel 1, Panel 2, Panel 3, Panel 4, Panel 5, Panel 6 |
| ORM-12741 IRImmediate release formulation of ORM-12741 | Drug | Panel 1, Panel 2, Panel 3, Panel 4, Panel 5, Panel 6 |
| ORM-12741 MR BModified release formulation of ORM-12741 | Drug | Panel 1, Panel 2, Panel 3, Panel 4, Panel 5, Panel 6 |
Primary outcome
Pharmacokinetics
Time frame: Blood samples collected frequently on day 1 and once or twice a day for 4 days
Explore the PK profile (e.g. Cmax, tmax, AUC, t1/2) and determine protein binding
1 secondary outcome
Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values
Time frame: 24 hours per period
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 6 May 2015.
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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 ORM-12741 MR A, ORM-12741 IR and ORM-12741 MR B in people with Healthy, 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 23 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 6 May 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 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 (time frame: Blood samples collected frequently on day 1 and once or twice a day for 4 days). 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 6 May 2015.