Positron Emission Tomagraphy (PET) Study Following a Single Oral Dose of OPC-34712
Phase 1
Completed
- Conditions
- Schizophrenia
- Registration Number
- NCT00805454
- 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 safety monitoring. Subjects will return to the clinic on Day 10 for a follow-up safety assessment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Males and non-child bearing potential females between 18 and 45 years of age, inclusive.
- BMI between 19 and 32 kg/m2, inclusive.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacodynamic: Percent occupancy of D2 receptor, as judged by PET scan. 10 days
- Secondary Outcome Measures
Name Time Method Measure safety: adverse events, vital signs, ECGs, and clinical laboratory tests 30 days