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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00805454
Recruitment Status : Completed
First Posted : December 9, 2008
Last Update Posted : May 7, 2010
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

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 Type : Interventional  (Clinical Trial)
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 : December 2008
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: OPC-34712
    Single oral dose, 0.5 to 25 mg

Primary Outcome Measures :
  1. Pharmacodynamic: Percent occupancy of D2 receptor, as judged by PET scan. [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Measure safety: adverse events, vital signs, ECGs, and clinical laboratory tests [ Time Frame: 30 days ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00805454

Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Principal Investigator: Dean Wong, MD,PhD Johns Hopkins University, Baltimore,MD 21287
Principal Investigator: Stephen Bart, MD SNBL, Baltimore,MD 21201

Responsible Party: Patricia Bricmont, PhD, Associate Director Clinical Pharmacology, Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier: NCT00805454     History of Changes
Other Study ID Numbers: 331-07-202
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: May 7, 2010
Last Verified: May 2010

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Healthy Volunteers
Phase I
Pet Scan

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders