Status:
COMPLETED
Early Clinical Evaluation of the Pharmacokinetics and Mechanism Based Pharmacodynamics of Haloperidol Using Positron Emission Tomography in Healthy Volunteers
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Seoul National University Hospital
Conditions:
Healthy
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief 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...
Detailed Description
1. Study Design This study will consist of two parts. One is "biodistribution study of haloperidol" in 12 subjects, and the other is "receptor occupancy study of haloperidol" in 12 subjects. In th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01193621
Start Date
January 1 2008
End Date
January 1 2012
Last Update
July 11 2013
Active Locations (1)
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1
Asan Medical Center
Seoul, Seoul, South Korea, 138-736