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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
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of ORM-12741.

Condition or disease Intervention/treatment Phase
Healthy Drug: ORM-12741 Drug: Placebo for ORM-12741 Phase 1

Detailed Description:
The purpose is to evaluate the safety, tolerability and pharmacokinetics of escalating multiple doses of ORM-12741 in healthy volunteers.

Study Design
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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
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values [ Time Frame: 12 days ]

Secondary Outcome Measures :
  1. Pharmacokinetic profile (Cmax, tmax, t1/2, AUC, PTF) of ORM-12741 and its metabolites [ Time Frame: PK samples will be collected for 12 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
France
Forenap Pharma
Rouffach, France
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Déborah Metzger, MD Forenap Pharma
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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