HealthyEarly Phase 1NCT00831077
Early Phase I Microdosing Study of ORM-14540 and ORM-12741
A Early Phase 1 study testing ORM-14540 and ORM-12741 in people with Healthy, 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 and ORM-14540 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
- What is being tested?
- ORM-14540 and ORM-12741
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2009to Apr 2009
- Phase
- Early 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.
- Males between 18 and 45 years (inclusive).
- Body Mass Index (BMI) between 18-30 kg/m2 (inclusive, BMI = weight/height2).
- Weight 55-100 kg (inclusive).
Who cannot join
- A predictable poor compliance or inability to communicate well with the investigator or study centre personnel.
- Veins unsuitable for repeated venipuncture
- Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric diseases 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 or less than 5 times a half-life of the medication. Possible enzyme inducing drugs will be discussed case-by-case with the sponsor.
Show all 21Show fewer
- 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 in 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 electrocardiogram (ECG) finding of clinical relevance in supine position after resting for 10 minutes 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.
- Heart rate (HR) < 45 beats/minute or > 100 beats/minute in supine position after resting for 10 minutes at the screening visit.
- At the screening visit, systolic blood pressure (BP) < 90 mmHg or > 140 mmHg in supine position after resting for 10 minutes, diastolic BP < 50 mmHg or > 90 mmHg in supine position after resting for 10 minutes.
- Any abnormal value of laboratory, vital signs, or 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 antigen/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 subject.
- Participation in a clinical drug study within 3 months prior to the screening visit in this study, or earlier participation in a clinical study with ORM-12741.
- Exposure to 14C-labelled drugs or diagnostics within 12 months prior to the screening visit.
- Men who are not practising clinically accepted method of contraception during the study and next 3 months after the study treatment administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Properties of ORM-14540 and ORM-12741 After Administration of a Microdose of 14C-labelled Drug; An Open, Non-randomised, Single Dose, Single Centre Study in Healthy Male Subjects
The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 and ORM-14540 in healthy volunteers.
- Conditions
- Healthy
- Being tested
- ORM-14540, ORM-12741
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORM-14540Drug
i.v.
ORM-12741Drug
i.v.
| Study group | Role | What they receive |
|---|---|---|
| 14C-ORM-14540 | Active comparator | Not described Receives: Drug: ORM-14540 |
| 14C-ORM-12741 | Active comparator | 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: Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) at the end of infusion, Terminal elimination half-life (t½z), Total clearance (CL)
Measured: 72 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: Before and after study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionApr 2009
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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT00831077
- Sponsor's protocol ID
- 3101001
- Status last verified
- Oct 2009
- First submitted
- 27 Jan 2009
- 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
- Pharmacokinetic Properties of ORM-14540 and ORM-12741 After Administration of a Microdose of 14C-labelled Drug; An Open, Non-randomised, Single Dose, Single Centre Study in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00831077
- Acronym / sponsor ID
- 3101001
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 28 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 and ORM-14540 in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 14C-ORM-14540 | Active comparator | Drug: ORM-14540 |
| 14C-ORM-12741 | Active comparator | 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.
- Males between 18 and 45 years (inclusive).
- Body Mass Index (BMI) between 18-30 kg/m2 (inclusive, BMI = weight/height2).
- Weight 55-100 kg (inclusive).
Key exclusion criteria (21 listed)
- A predictable poor compliance or inability to communicate well with the investigator or study centre personnel.
- Veins unsuitable for repeated venipuncture
- Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric diseases 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-14540i.v. | Drug | 14C-ORM-14540 |
| ORM-12741i.v. | Drug | 14C-ORM-12741 |
Primary outcome
Pharmacokinetic variables including: Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) at the end of infusion, Terminal elimination half-life (t½z), Total clearance (CL)
Time frame: 72 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: Before and after 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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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 Early Phase 1 study testing ORM-14540 and ORM-12741 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 5 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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: Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) at the end of infusion, Terminal elimination half-life (t½z), Total clearance (CL) (time frame: 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 8 Oct 2009.