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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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OPC-34712

Single oral dose, 0.5 to 25 mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes