HealthyPhase 1NCT00792493
Safety and Tolerability Study With Multiple Ascending Doses of ORM-12741
A Phase 1 study testing ORM-12741 in people with Healthy, run by Orion Corporation, Orion Pharma at 1 site in France.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of escalating multiple doses 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
- What is being tested?
- ORM-12741
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to Sep 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
- Good general health ascertained by detailed medical history and physical examinations
- Males between 18 and 45 years
- Body mass index (BMI) between 18-30 kg/m2
- Weight 55-90 kg
Who cannot join
- Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease
- Any condition requiring regular concomitant treatment including herbal products or likely to need any concomitant treatment during the study
- Susceptibility to severe allergic reactions
- Regular consumption of more than 14 units of alcohol per week
- Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
- Inability to refrain from using nicotine-containing products during the stay in the study centre
Show all 10Show fewer
- Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre
- Blood donation or loss of significant amount of blood within 3 months prior to the screening visit
- Abnormal finding in ECG, vital signs, laboratory tests or physical examination
- Participation in a drug study within 3 months prior to the start of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study With Multiple Ascending Doses of ORM-12741
The purpose of this study is to evaluate the safety and tolerability of escalating multiple doses of ORM-12741 in healthy volunteers
- Conditions
- Healthy
- Being tested
- ORM-12741
- Keywords
- Healthy volunteer study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORM-12741Drug
Alternating panel multiple dose escalation
| Study group | Role | What they receive |
|---|---|---|
| ORM-12741 | Experimental | Not described Receives: Drug: ORM-12741 |
| Placebo | Placebo comparator | Not described Receives: Drug: ORM-12741 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values
Measured: about a month
Secondary outcomes (1)
Pharmacokinetics
Measured: 12 days 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 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionSep 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Déborah Metzger, Medical Doctor, Principal investigator, Forenap Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792493
- Sponsor's protocol ID
- 3098002
- Status last verified
- Sep 2009
- First submitted
- 17 Nov 2008
- Last updated
- 24 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study With Multiple Ascending Doses of ORM-12741
- ClinicalTrials.gov ID
- NCT00792493
- Acronym / sponsor ID
- 3098002
- Conditions
- Healthy
- Keywords
- Healthy volunteer study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 18 Nov 2008 (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 multiple doses of ORM-12741 in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ORM-12741 | Experimental | Drug: ORM-12741 |
| Placebo | Placebo comparator | Drug: ORM-12741 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Good general health ascertained by detailed medical history and physical examinations
- Males between 18 and 45 years
- Body mass index (BMI) between 18-30 kg/m2
- Weight 55-90 kg
Key exclusion criteria (10 listed)
- Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease
- Any condition requiring regular concomitant treatment including herbal products or likely to need any concomitant treatment during the study
- Susceptibility to severe allergic reactions
- Regular consumption of more than 14 units of alcohol per week
- Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
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-12741Alternating panel multiple dose escalation | Drug | ORM-12741, Placebo |
Primary outcome
Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values
Time frame: about a month
1 secondary outcome
Pharmacokinetics
Time frame: 12 days 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 24 Sep 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.
Déborah Metzger, Medical Doctor principal investigator
Forenap 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, run by Orion Corporation, Orion Pharma at 1 site in France.
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 4 inclusion and 10 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 24 Sep 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 France. 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?
Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values (time frame: about a month). 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 24 Sep 2009.