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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: OPC-34712

Study type: Interventional

Funder types: Industry

Identifiers

NCT00805454

331-07-202

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.