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

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00805454

Collaborator

Otsuka Pharmaceutical Co., Ltd. (Industry)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: OPC-34712	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Phase I, Open-Label,Positron Emission Tomography (PET) Study Healthy Subjects Following a Single Oral Dose of OPC-34712

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Outcome Measures

Primary Outcome Measures

Pharmacodynamic: Percent occupancy of D2 receptor, as judged by PET scan. [10 days]

Secondary Outcome Measures

Measure safety: adverse events, vital signs, ECGs, and clinical laboratory tests [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.

Investigators

Principal Investigator: Dean Wong, MD,PhD, Johns Hopkins University, Baltimore,MD 21287
Principal Investigator: Stephen Bart, MD, SNBL, Baltimore,MD 21201

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00805454

Other Study ID Numbers:

331-07-202

First Posted:

Dec 9, 2008

Last Update Posted:

May 7, 2010

Last Verified:

May 1, 2010

Keywords provided by , ,

Healthy Volunteers

Phase I

Pet Scan

Additional relevant MeSH terms:

Schizophrenia

Study Results

No Results Posted as of May 7, 2010