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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00693316
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : February 11, 2010
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma

Tracking Information
First Submitted Date  ICMJE May 30, 2008
First Posted Date  ICMJE June 9, 2008
Last Update Posted Date February 11, 2010
Study Start Date  ICMJE July 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2008)
Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values [ Time Frame: About 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2008)
Pharmacokinetics [ Time Frame: 5 days after each dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability Study With Single Ascending Doses of ORM-12741
Official Title  ICMJE Phase I Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study With Single Ascending Doses of ORM-12741
Brief Summary The purpose of this study is to evaluate the safety and tolerability of escalating doses of ORM-12741 in healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: ORM-12741
Alternating panel single dose escalation.
Study Arms  ICMJE
  • Experimental: ORM-12741
    Intervention: Drug: ORM-12741
  • Placebo Comparator: Placebo
    Intervention: Drug: ORM-12741
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 23, 2009)
120
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2008)
72
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00693316
Other Study ID Numbers  ICMJE 3098001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jutta Hänninen, Clinical study manager, Orion corporation, Orion Pharma
Study Sponsor  ICMJE Orion Corporation, Orion Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Déborah Metzger, MD Forenap Pharma
PRS Account Orion Corporation, Orion Pharma
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP