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

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

OPC-34712

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring Healthy Volunteers, Phase I, Pet Scan

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00805454

First Posted

December 4, 2008

Last Updated

May 6, 2010

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Otsuka Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00805454

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

Healthy Volunteers, Phase I, Pet Scan

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Masking

None (Open Label)

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

OPC-34712

Intervention Description

Single oral dose, 0.5 to 25 mg

Primary Outcome Measure Information:

Title

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

Time Frame

10 days

Secondary Outcome Measure Information:

Title

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

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dean Wong, MD,PhD

Organizational Affiliation

Johns Hopkins University, Baltimore,MD 21287

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stephen Bart, MD

Organizational Affiliation

SNBL, Baltimore,MD 21201

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

33196868

Citation

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. Erratum In: Eur J Clin Pharmacol. 2021 Jan 4;:

Results Reference

derived

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

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