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

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00693316
First received: May 30, 2008
Last updated: February 10, 2010
Last verified: February 2010
  Purpose

The purpose of this study is to evaluate the safety and tolerability of escalating 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 Single 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 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 5 days after each dose ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: July 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ORM-12741 Drug: ORM-12741
Alternating panel single dose escalation.
Placebo Comparator: Placebo Drug: ORM-12741
Alternating panel single 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693316

Locations
France
Forenap Pharma
Rouffach, France, 68250
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Déborah Metzger, MD Forenap Pharma
  More Information

No publications provided

Responsible Party: Jutta Hänninen, Clinical study manager, Orion corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT00693316     History of Changes
Other Study ID Numbers: 3098001
Study First Received: May 30, 2008
Last Updated: February 10, 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 April 15, 2014