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OpenTrials
Completed

NCT Number: NCT00829907

A PET Study With ORM-12741

The purpose of the study is to evaluate the effect of ORM-12741 on receptor occupancy by positron emission tomography with different doses and plasma concentrations. The pharmacokinetic profile and safety will also be evaluated.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Turku PET centre

Turku, 20520, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Good general health ascertained by detailed medical history and physical examination
  • Males between 18 and 45 years
  • Body mass index (BMI; weight/height2) between 18-30 kg/m2
  • Weight 55-95 kg

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
  • Regular consumption of more than 21 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 for 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 12-lead electrocardiogram (ECG) finding of clinical relevance
  • Any abnormal value of laboratory, vital signs, or physical examination, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk for the subject if he takes part into the study
  • Anatomical abnormality in brain MRI which may in the opinion of the investigator interfere with the interpretation of the PET results
  • Participation in another clinical drug study within 3 months prior to the start of this study or earlier participation in a clinical study with ORM-12741
  • Participation in a prior PET study
  • Any contraindication to MRI of the brain

Treatment and study plan

ORM-12741

Drug

Single dose as a capsule, oral administration

Primary outcomes

  1. Receptor occupancy

    Time frame: 1 day

Secondary outcomes

  1. Pharmacokinetic variables including peak concentration in plasma, time to peak concentration, area under the plasma concentration-time curve

    Time frame: 1 day

  2. Safety variables including blood pressure, heart rate, electrocardiogram, physical examination, laboratory safety variables (haematology, chemistry, serology, urinanalysis) and adverse events.

    Time frame: During the study

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

Effect of ORM-12741 on Receptor Occupancy Studied by Positron Emission Tomography; an Open, Single Dose, Dose Ranging Study in Healthy Males

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 27, 2009
Registry last updated
Nov 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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