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
  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
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
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

No publications provided

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 April 23, 2014