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

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01068028
First received: February 10, 2010
Last updated: August 13, 2010
Last verified: August 2010
History of Changes

February 10, 2010
August 13, 2010
February 2010
June 2010   (final data collection date for primary outcome measure)
Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01068028 on ClinicalTrials.gov Archive Site
Pharmacokinetic profile (Cmax, tmax, t1/2, AUC, PTF) of ORM-12741 and its metabolites [ Time Frame: PK samples will be collected for 12 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Pharmacokinetic Study With Multiple Ascending Doses of ORM-12741
Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of ORM-12741

The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of ORM-12741.

The purpose is to evaluate the safety, tolerability and pharmacokinetics of escalating multiple doses of ORM-12741 in healthy volunteers.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
  • Drug: ORM-12741
    Ascending multiple doses to sequential panels
  • Drug: Placebo for ORM-12741
  • Placebo Comparator: Placebo for ORM-12741
    Intervention: Drug: Placebo for ORM-12741
  • Experimental: ORM-12741
    Intervention: Drug: ORM-12741
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
July 2010
June 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01068028
3098008
Yes
Jutta Hänninen / Clinical Study Manager, Orion Corporation, Orion Pharma
Orion Corporation, Orion Pharma
Not Provided
Principal Investigator: Déborah Metzger, MD Forenap Pharma
Orion Corporation, Orion Pharma
August 2010

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