Research with human participants

Overview of medical research in the Netherlands

A FIRST-IN-HUMAN SINGLE-DOSE ESCALATION STUDY OF THE SAFETY AND PHARMACOLOGY OF LY2165766 INCLUDING BRAIN DOPAMINE D2 RECEPTOR OCCUPANCY BY POSITRON EMISSION TOMOGRAPHY (PET)

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Last updated:

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Schizophrenia and other psychotic disorders
Study type
Interventional

ID

NL-OMON33530

Source

ToetsingOnline

Brief title

LY2165766 SDSS/PET study

Condition

  • Schizophrenia and other psychotic disorders

Synonym

schizophrenia

Research involving

Human

Sponsors and support

Primary sponsor :
Chorus LRL (devisie van Eli Lilly)
Source(s) of monetary or material Support :
sponsor van dit onderzoek

Intervention

Keyword :
LY2165766, schizophrenia

Outcome measures

Primary outcome

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Secondary outcome

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Background summary

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Study objective

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Study design

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Intervention

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Study burden and risks

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Public
Chorus LRL (devisie van Eli Lilly)

550 North University Blvd
Indianapolis, IN 46202
Verenigde Staten van Amerika
Scientific
Chorus LRL (devisie van Eli Lilly)

550 North University Blvd
Indianapolis, IN 46202
Verenigde Staten van Amerika

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

healthy male
Part A: 18 - 65 year.
Part B: 35 - 65 year
Part C: 35 - 65 year

Exclusion criteria

Relevant disease in medical history

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Double blinded (masking used)
Control :
Placebo
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
38
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
[11C] Raclopride
Generic name :
nvt
Registration
:
Yes - NL outside intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)
Approved WMO
Date :
Application type :
First submission
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
BEBO: Stichting Beoordeling Ethiek Bio-Medisch Onderzoek (Assen)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
EudraCT EUCTR2008-005287-14-NL
CCMO NL24758.056.08