Positron Emission Tomagraphy (PET) Study Following a Sing... | NCT00805454

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

NCT00805454

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Status

Completed

Last Update Posted

May 7, 2010Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

Schizophrenia

Interventions

OPC-34712

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Dec 4, 2008

First Submission Date that Met QC Criteria

Dec 8, 2008

First Posted Date

Dec 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2010

Last Update Posted Date

May 7, 2010Estimated

Name	Class
Otsuka Pharmaceutical Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Name	Type	Description	Arm Group Labels	Other Names
OPC-34712	Drug	Single oral dose, 0.5 to 25 mg

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33196868	Derived	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.

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders