NCT00829907

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jan 2009

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2008

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

5 months

First QC Date

December 11, 2008

Last Update Submit

November 23, 2009

Conditions

Healthy

Keywords

Healthy volunteer study

Outcome Measures

Primary Outcomes (1)

  • Receptor occupancy

    1 day

Secondary Outcomes (2)

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

    1 day

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

    During the study

Study Arms (1)

1

EXPERIMENTAL

Orm-12741

Drug: ORM-12741

Interventions

ORM-12741DRUG

Single dose as a capsule, oral administration

1

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku PET centre

Turku, 20520, Finland

Location

Related Publications (1)

  • Shahid M, Rinne JO, Scheinin M, Virta J, Marjamaki P, Solin O, Arponen E, Sallinen J, Kuokkanen K, Rouru J. Application of the PET ligand [11C]ORM-13070 to examine receptor occupancy by the alpha2C-adrenoceptor antagonist ORM-12741: translational validation of target engagement in rat and human brain. EJNMMI Res. 2020 Dec 9;10(1):152. doi: 10.1186/s13550-020-00741-y.

    PMID: 33296042DERIVED

MeSH Terms

Interventions

ORM-12741

Study Officials

  • Juha Rinne, MD, PhD

    Turku PET Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 11, 2008

First Posted

January 27, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

FI(1)