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

May 6, 2010 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

15

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamic: Percent occupancy of D2 receptor, as judged by PET scan.
Time Frame: 10 days
10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure safety: adverse events, vital signs, ECGs, and clinical laboratory tests
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 8, 2008

First Posted (Estimate)

December 9, 2008

Study Record Updates

Last Update Posted (Estimate)

May 7, 2010

Last Update Submitted That Met QC Criteria

May 6, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 331-07-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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