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

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00792493
First received: November 17, 2008
Last updated: September 23, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Healthy
Drug: 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: Phase I Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study With Multiple Ascending 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: about a month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 12 days per period ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: December 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ORM-12741 Drug: ORM-12741
Alternating panel multiple dose escalation
Placebo Comparator: Placebo Drug: ORM-12741
Alternating panel multiple dose escalation

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
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
  • 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
  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: NCT00792493

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

No publications provided

Responsible Party: Jutta Hänninen, Clinical Study Manager, Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT00792493     History of Changes
Other Study ID Numbers: 3098002
Study First Received: November 17, 2008
Last Updated: September 23, 2009
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 July 29, 2014