Healthy VolunteersPhase 1NCT00818740
Pharmacokinetic Study of ORM-12741 in Healthy Volunteers
A Phase 1 study testing ORM-12741 in people with Healthy Volunteers, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 in healthy 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 Volunteers
- What is being tested?
- ORM-12741
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2009to Jun 2009
- 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
- Written informed consent (IC) obtained.
- Good general health ascertained by detailed medical history and physical examinations.
- Finnish speaking males between 18 and 45 years of age (inclusive).
- Body Mass Index (BMI) between 18-30 kg/m2 (inclusive, BMI = weight/height2).
- Weight of 55-100 kg (inclusive).
Who cannot join
- A predictable poor compliance or inability to communicate well with the investigator.
- Veins unsuitable for repeated venipuncture.
- 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 medication including herbal products or likely to need any concomitant treatment during the study.
- 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 a half-live 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 (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 in getting headache when refraining from caffeine-containing beverages.
- Blood donation or loss of significant amount of blood within 2 months prior to the screening visit.
- Abnormal 12-lead ECG finding of clinical relevance after 10-minute rest in supine position at the screening visit, for example:
- QTc (calculated through the Bazett's formula) > 450msec,
- PR < 120 msec or > 210 msec,
- QRS < 70 msec or > 120 msec.
- HR < 45 beats/minute or > 100 beats/minute after 10-minute rest in supine position at the screening visit.
- At the screening visit systolic blood pressure (BP) < 90 mmHg or > 140 mmHg after 10 minutes in supine position, diastolic BP < 50 mmHg or > 90 mmHg after 10 minutes in supine position.
- Any abnormal value of laboratory, vital signs, physical examination, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk for the subject if he takes part into 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).
- 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: Pharmacokinetics of ORM-12741 After Intravenous and Oral Administration and Effects of Food on ORM-12741 Pharmacokinetics; An Open, Randomised, Single Dose, Single Centre, Crossover Study in Healthy Male Subjects
The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- ORM-12741
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORM-12741Drug
i.v., oral solution and oral capsule forms. Oral capsule given with and without food.
| Study group | Role | What they receive |
|---|---|---|
| ORM-12741 i.v. | Experimental | Not described Receives: Drug: ORM-12741 |
| ORM-12741 oral solution | Experimental | Not described Receives: Drug: ORM-12741 |
| ORM-12741 oral capsule with food | Experimental | Not described Receives: Drug: ORM-12741 |
| ORM-12741 oral capsule without food | Experimental | Not described Receives: Drug: ORM-12741 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic variables including: Peak concentration in plasma (Cmax), Time to peak concentration in plasma (tmax), Area under the plasma concentration-time curve (AUC)
Measured: 96 hours
Secondary outcomes (1)
Safety variables including blood pressure (BP), heart rate (HR), electrocardiograms (ECGs), physical examination, laboratory safety variables (haematology, chemistry, serology and urinalysis) and adverse events (AEs).
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Juha Peltonen, MD, Principal investigator, CRSTVirpi Mononen, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818740
- Sponsor's protocol ID
- 3098003
- Status last verified
- Oct 2009
- First submitted
- 22 Dec 2008
- Last updated
- 8 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of ORM-12741 After Intravenous and Oral Administration and Effects of Food on ORM-12741 Pharmacokinetics; An Open, Randomised, Single Dose, Single Centre, Crossover Study in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00818740
- Acronym / sponsor ID
- 3098003
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 8 Jan 2009 (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 determine pharmacokinetic parameters of ORM-12741 in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ORM-12741 i.v. | Experimental | Drug: ORM-12741 |
| ORM-12741 oral solution | Experimental | Drug: ORM-12741 |
| ORM-12741 oral capsule with food | Experimental | Drug: ORM-12741 |
| ORM-12741 oral capsule without food | Experimental | Drug: ORM-12741 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written informed consent (IC) obtained.
- Good general health ascertained by detailed medical history and physical examinations.
- Finnish speaking males between 18 and 45 years of age (inclusive).
- Body Mass Index (BMI) between 18-30 kg/m2 (inclusive, BMI = weight/height2).
- Weight of 55-100 kg (inclusive).
Key exclusion criteria (22 listed)
- A predictable poor compliance or inability to communicate well with the investigator.
- Veins unsuitable for repeated venipuncture.
- 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 medication including herbal products or likely to need any concomitant treatment during the study.
- 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-12741i.v., oral solution and oral capsule forms. Oral capsule given with and without food. | Drug | ORM-12741 i.v., ORM-12741 oral capsule with food, ORM-12741 oral capsule without food, ORM-12741 oral solution |
Primary outcome
Pharmacokinetic variables including: Peak concentration in plasma (Cmax), Time to peak concentration in plasma (tmax), Area under the plasma concentration-time curve (AUC)
Time frame: 96 hours
1 secondary outcome
Safety variables including blood pressure (BP), heart rate (HR), electrocardiograms (ECGs), physical examination, laboratory safety variables (haematology, chemistry, serology and urinalysis) and adverse events (AEs).
Time frame: throughout the study
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 8 Oct 2009.
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Screening Protocol
Pain
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.
Juha Peltonen, MD principal investigator
CRST
Virpi Mononen 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 ORM-12741 in people with Healthy Volunteers, 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 5 inclusion and 22 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 8 Oct 2009. 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?
Pharmacokinetic variables including: Peak concentration in plasma (Cmax), Time to peak concentration in plasma (tmax), Area under the plasma concentration-time curve (AUC) (time frame: 96 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 8 Oct 2009.