Schizophrenia
Conditions
Keywords
Healthy Volunteers, Phase I, Pet Scan
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.
Interventions
DRUGOPC-34712
Single oral dose, 0.5 to 25 mg
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamic: Percent occupancy of D2 receptor, as judged by PET scan. | 10 days |
Secondary
| Measure | Time frame |
|---|---|
| Measure safety: adverse events, vital signs, ECGs, and clinical laboratory tests | 30 days |
Outcome results
None listed