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

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00805454
First received: December 4, 2008
Last updated: May 6, 2010
Last verified: May 2010
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: OPC-34712
Phase 1

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Pharmacodynamic: Percent occupancy of D2 receptor, as judged by PET scan. [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure safety: adverse events, vital signs, ECGs, and clinical laboratory tests [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: December 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: OPC-34712
    Single oral dose, 0.5 to 25 mg
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00805454

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
  More Information

No publications provided

Responsible Party: Patricia Bricmont, PhD, Associate Director Clinical Pharmacology, Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00805454     History of Changes
Other Study ID Numbers: 331-07-202
Study First Received: December 4, 2008
Last Updated: May 6, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014