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

Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: haloperidol, PET (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Asan Medical Center

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: plasma haloperidol concentration

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 the biodistribution study, 18F-haloperidol (10 mCi) will be injected intravenously two times into each of the 12 subjects (cross-over design). Whole body PET will be conducted after the first haloperidol injection and local brain PET after the 2nd haloperidol injection after the 7 day washout period. 1. 1 D2-receptor occupancy study Group Doses No. of subjects 1 0. 5 mg 4 2 1 mg 4 3 3 mg 4 2. Measurement 2. 1 The D2 receptor Occupancy of haloperidol. 3. Test schedule 3. 1 Biodistribution study

- Whole body PET (day 1)

- Brain local PET (day 8) 3. 2 Receptor occupancy study

- Baseline PET before drug administration (day 1 0h), 6h (day 1 6h), 24h (day 2 0h),

after the first haloperidol administration (day 1 0h), and 24 h (day 8), 72 h (day 10), and 168 h (day 14) after the last dosing of haloperidol (day 7 0h).

- Drug administration from day 1 through day 7 every 24 hours PK blood sampling (6

ml, each) prior to the first haloperidol administration (day 1 0h) and 6h (1 day 6h), 24h (2 day 0h), 48 h (3 day 0h), 96 h (5 day 0h), 144 h (7 day 0h) and, 0. 5, 1, 2, 4, 6, 8, 12, 24 h (8day 0h), 48h (9day 0h), 72h (10 day 0h) after taking the last oral dose of haloperidol 4. Analytic Methods 4. 1 Pharmacokinetics: Noncompartmental Analysis Using Winnonlin Compartment model using NONMEM VII 4. 2 Pharmacodynamics in the brain: Emax or linear model using NONMEM VII

Eligibility

Minimum age: 19 Years. Maximum age: 45 Years. Gender(s): Male.

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

Locations and Contacts

Asan Medical Center, Seoul 138-736, Korea, Republic of
Additional Information

Starting date: January 2008
Last updated: July 10, 2013

Page last updated: August 23, 2015

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