NCT00805454

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 schizophrenia

Timeline
Completed

Started Dec 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 7, 2010

Status Verified

May 1, 2010

Enrollment Period

7 months

First QC Date

December 4, 2008

Last Update Submit

May 6, 2010

Conditions

Schizophrenia

Keywords

Healthy VolunteersPhase IPet Scan

Outcome Measures

Primary Outcomes (1)

  • Pharmacodynamic: Percent occupancy of D2 receptor, as judged by PET scan.

    10 days

Secondary Outcomes (1)

  • Measure safety: adverse events, vital signs, ECGs, and clinical laboratory tests

    30 days

Interventions

OPC-34712DRUG

Single oral dose, 0.5 to 25 mg

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and non-child bearing potential females between 18 and 45 years of age, inclusive.
  • BMI between 19 and 32 kg/m2, inclusive.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wong DF, Raoufinia A, Bricmont P, Brasic JR, McQuade RD, Forbes RA, Kikuchi T, Kuwabara H. An open-label, positron emission tomography study of the striatal D2/D3 receptor occupancy and pharmacokinetics of single-dose oral brexpiprazole in healthy participants. Eur J Clin Pharmacol. 2021 May;77(5):717-725. doi: 10.1007/s00228-020-03021-9. Epub 2020 Nov 16.

    PMID: 33196868DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Dean Wong, MD,PhD

    Johns Hopkins University, Baltimore,MD 21287

    PRINCIPAL INVESTIGATOR

  • Stephen Bart, MD

    SNBL, Baltimore,MD 21201

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
BASIC SCIENCE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 4, 2008

First Posted

December 9, 2008

Study Start

December 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

May 7, 2010

Record last verified: 2010-05