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Safety and Tolerability Study With Multiple Ascending Doses of ORM-12741

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ClinicalTrials.gov Identifier: NCT00792493
Recruitment Status : Completed
First Posted : November 18, 2008
Last Update Posted : September 24, 2009
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of escalating multiple doses of ORM-12741 in healthy volunteers

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study With Multiple Ascending Doses of ORM-12741
Study Start Date : December 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: ORM-12741 Drug: ORM-12741
Alternating panel multiple dose escalation
Placebo Comparator: Placebo Drug: ORM-12741
Alternating panel multiple dose escalation



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

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 12 days per period ]


Information from the National Library of Medicine

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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
  • Body mass index (BMI) between 18-30 kg/m2
  • Weight 55-90 kg

Exclusion Criteria:

  • 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
  • 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

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): NCT00792493


Locations
France
Forenap Pharma
Rouffach, France
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Déborah Metzger, Medical Doctor Forenap Pharma

Responsible Party: Jutta Hänninen, Clinical Study Manager, Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT00792493     History of Changes
Other Study ID Numbers: 3098002
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: September 24, 2009
Last Verified: September 2009

Keywords provided by Orion Corporation, Orion Pharma:
Healthy volunteer study