Positron Emission Tomagraphy (PET) Study Following a Single Oral Dose of OPC-34712

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Determine the degree of striatal D2 receptor occupancy induced by OPC-34712 at differenht dose levels in healthy volunteers.

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

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborator: Otsuka Pharmaceutical Co., Ltd.

Criteria

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.