F-18 Altanserin PET Study of Patients Receiving Clozapine

• Status: Unknown status
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To examine the feasibility of molecular imaging markers in clinical psychopharmacology

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Treatments: Clozapine

Criteria

Inclusion Criteria:

• Overtly healthy males as determined by medical history and physical examination

• Age from 19 to 45 years

• Weight ≥ 45 kg and within ± 20% of IBW

• Clinical laboratory test results within normal reference range for the National Cancer Center, Hospital or results with minor deviations which are judged to be not clinically significant by the investigator

• Normal blood pressure and heart rate (supine and standing) as determined by the investigator

• Are reliable and willing to make themselves available for the duration of the study, and who will abide by the study restrictions

• Have given written informed consent

Exclusion Criteria:

• Evidence of significant active hematologic disease

• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication

• An episode of febrile disease or infectious disease within the past 2 weeks

• Evidence of significant active neuropsychiatric disease

• Regular use of drugs or abuse

• History of drug hypersensitivity or clinically significant allergic reactions of any origin

• Participation in a study involving administration of an investigational compound within the past 30 days

• Use of any current medication

• Smoking history for recent 3 months