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CompletedNCT00792493Updated Sep 24, 2009

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

A Phase 1 interventional study of ORM-12741 in Healthy, sponsored by Orion Corporation, Orion Pharma. Completed at 1 site in France. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-09-24.

Sponsored by Orion Corporation, Orion Pharma · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • Healthy volunteer study
03

In context

Lead sponsor

Orion Corporation, Orion Pharma is the lead sponsor of 100 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    ORM-12741

    Drug: ORM-12741

  • Placebo comparator
    Placebo

    Drug: ORM-12741

Interventions

  • DrugORM-12741

    Alternating panel multiple dose escalation

06

What researchers measure

Primary outcomes

  1. Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values

    Time frame: about a month

Secondary outcomes

  1. Pharmacokinetics

    Time frame: 12 days per period

07

Study locations

1 site
  • Forenap Pharma
    Rouffach, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00792493
Lead sponsor
Orion Corporation, Orion Pharma
First posted
Nov 18, 2008
Start date
Dec 2008
Primary completion
Jun 2009
Completion
Sep 2009
Last update
Sep 24, 2009

Study contacts

Déborah Metzger, Medical Doctor
principal investigator · Forenap Pharma

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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