Safety and Pharmacokinetic Study With Multiple Ascending Doses of ORM-12741
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ClinicalTrials.gov Identifier: NCT01068028 |
Recruitment Status
:
Completed
First Posted
: February 12, 2010
Last Update Posted
: August 16, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: ORM-12741 Drug: Placebo for ORM-12741 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 49 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of ORM-12741 |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | July 2010 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo for ORM-12741 | Drug: Placebo for ORM-12741 |
Experimental: ORM-12741 |
Drug: ORM-12741
Ascending multiple doses to sequential panels
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- Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values [ Time Frame: 12 days ]
- Pharmacokinetic profile (Cmax, tmax, t1/2, AUC, PTF) of ORM-12741 and its metabolites [ Time Frame: PK samples will be collected for 12 days ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, 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 medication during the study.
- Susceptibility to severe allergic reactions.
- Regular consumption of more than 14 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 3 months prior to the screening visit.
- Abnormal finding in ECG, vital signs, laboratory tests or physical examination.
- Intake of an investigational compound within 3 months prior to the start of this study or earlier participation in a clinical study with ORM-12741

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01068028
France | |
Forenap Pharma | |
Rouffach, France |
Principal Investigator: | Déborah Metzger, MD | Forenap Pharma |
Responsible Party: | Jutta Hänninen / Clinical Study Manager, Orion Corporation, Orion Pharma |
ClinicalTrials.gov Identifier: | NCT01068028 History of Changes |
Other Study ID Numbers: |
3098008 |
First Posted: | February 12, 2010 Key Record Dates |
Last Update Posted: | August 16, 2010 |
Last Verified: | August 2010 |
Keywords provided by Orion Corporation, Orion Pharma:
Healthy volunteer study |