Status:
COMPLETED
Positron Emission Tomagraphy (PET) Study Following a Single Oral Dose of OPC-34712
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Determine the degree of striatal D2 receptor occupancy induced by OPC-34712 at differenht dose levels in healthy volunteers.
Detailed Description
Subjects will receive a dose of study medication and will undergo a PET scan at 4 hrs and 23.5 hours post dose. Subjects will remain in the clinic from Day-1 to Day 7 for PK sample collection and safe...
Eligibility Criteria
Inclusion
- Males and non-child bearing potential females between 18 and 45 years of age, inclusive.
- BMI between 19 and 32 kg/m2, inclusive.
Exclusion
- Condition or history which may present a safety concern to the subject or interfere with outcome variables.
- History of or current drug or alcohol abuse, hepatitis, AIDS, or drug allergy.
- Use of prescription, over-the-counter, or herbal medication, or vitamin supplements within 14 days or antibiotics within 30 days.
- Use of tobacco products or daily exposue to second hand smoke.
- Blood pressure higher than 140/90 mmHg or lower than 100/50 mmHg: heart rate outside 40 to 90 beats/minute.
- History of serious mental disorder.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00805454
Start Date
December 1 2008
End Date
July 1 2009
Last Update
May 7 2010
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