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

Condition Intervention Phase
Healthy
 Drug: ORM-12741
Drug: Placebo for ORM-12741
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of ORM-12741

Further study details as provided by Orion Corporation, Orion Pharma:

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

Secondary Outcome Measures:
  • 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 ]
Enrollment: 49
Study Start Date: February 2010
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo for ORM-12741 Drug: Placebo for ORM-12741
Experimental: ORM-12741 Drug: ORM-12741
Ascending multiple doses to sequential panels

Detailed Description:
The purpose is to evaluate the safety, tolerability and pharmacokinetics of escalating multiple doses of ORM-12741 in healthy volunteers.
  Eligibility
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068028

Locations
France
Forenap Pharma
Rouffach, France
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Déborah Metzger, MD Forenap Pharma
  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 
Study First Received: February 10, 2010
Last Updated: August 13, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 27, 2016