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Completed

NCT Number: NCT00805454

Positron Emission Tomagraphy (PET) Study 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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OPC-34712

Drug

Single oral dose, 0.5 to 25 mg

Primary outcomes

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

    Time frame: 10 days

Secondary outcomes

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

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 9, 2008
Registry last updated
May 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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