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Completed

NCT Number: NCT01613703

ONO-2952 Single-dose PET Study in Healthy Adult Subjects

The primary objective of this study is to evaluate the brain TSPO occupancy of ONO-2952 in healthy adult subjects after a single dose using [11C]PBR28 as a specific PET ligand for TSPO. The secondary objective is to evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952 and to investigate the safety and tolerability of ONO-2952 in healthy subjects.

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Key information

Conditions

Healthy Adult Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pittsburgh Clinical Site

Pittsburgh, Pennsylvania, 15218, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy non-smoking male or female subjects (18-55 inclusive)
  • Body mass index (BMI) of 19-35 kg/m2 (inclusive)
  • For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception

Exclusion criteria

  • History or presence of clinically significant disease

Treatment and study plan

ONO-2952

Drug

1 mg to 200 mg QD at a single descending dose

Primary outcomes

  1. To evaluate the brain TSPO occupancy of ONO-2952 in healthy adult subjects after a single dose using [11C]PBR28 as a specific PET ligand for TSPO

    Time frame: 2 days

Secondary outcomes

  1. To evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952

    Time frame: 2 days

  2. To investigate the safety and tolerability of ONO-2952 in healthy adult subjects

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Ono Pharma USA Inc

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

Open-Label, Single-Center, Single Dose Positron Emission Topography (PET) Using [11C]PBR28 to Evaluate Brain Translocator Protein 18KDa (TSPO) Occupancy of ONO-2952 in Healthy Adult Subjects

Important dates

Study start
2012
Primary completion
2013
First posted
Jun 7, 2012
Registry last updated
Jun 3, 2013

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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