Early Clinical Evaluation of the Pharmacokinetics and Mechanism Based Pharmacodynamics of Haloperidol Using Positron Emission Tomography in Healthy Volunteers

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

In the present study, the investigators will establish the clinical trial technology for early evaluation of drug characteristics in terms of pharmacokinetics and pharmacodynamics for haloperidol as a model drug, using positron emission tomography.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: Seoul National University Hospital
• Treatments: Haloperidol; Haloperidol decanoate

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:

• 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 hematologic disease and/or blood donation in the last 2 months

• 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

• Have a regular alcohol intake greater than 21 units/week or subjects unwilling to stop alcohol for the duration of the study periods

• Intend to use concomitant drug therapy, including non prescription medication on a regular basis apart from vitamin/mineral supplements

• Smoking history for recent 3 months

• Use of medication within 7 days prior to the study. If this situation arises inclusion of an otherwise suitable volunteer may be at the discretion of the investigator