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An Open-Label, Single Dose Study to Investigate Striatal Dopamine D2 Receptor Binding of JNJ-37822681 Using [11C]Raclopride Positron Emission Tomography in Healthy Male Subjects

An Open-Label, Single Dose Study to Investigate Striatal Dopamine D2 Receptor Binding of JNJ-37822681 Using [11C]Raclopride Positron Emission Tomography in Healthy Male Subjects - PET study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30989
Enrollment
8
Registered
2007-08-07
Start date
2007-09-15
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

schizophrenia

Interventions

Each subject will receive 2 dose levels of JNJ-37822681 and 3 [11C]raclopride PET scans.

Sponsors

Johnson & Johnson Pharmaceutical
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects between 18 - 55 years of age BMI between 18 and 30 kg/m²

Exclusion criteria

Exclusion criteria: History of, or currently active, significant illness or medical disorder Yearly cumulative dose due to exposure to radiation above 10 mSv Any significant MR abnormalities as determined by a neuroradiologist Metal implants Claustrophobia History of epilepsy or fits or unexplained black-outs Significant history of or current psychiatric or neurological disease

Design outcomes

Primary

MeasureTime frame
Dopamine D2 receptor binding is measured and the relation between the pharmacokintetics of JNJ-37822681 and the receptor binding is determined. safety and tolerability, adverse events, changes in blood pressure, pulse rate, lab. safety data, 12-lead ECG and physical examination and also studied.

Secondary

MeasureTime frame
n.a.p.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)