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

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ClinicalTrials.gov Identifier: NCT01613703
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : June 3, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Adult Subjects Drug: ONO-2952 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2012
Primary Completion Date : March 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: Experimental Drug: ONO-2952
1 mg to 200 mg QD at a single descending dose


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613703


Locations
United States, Pennsylvania
Pittsburgh Clinical Site
Pittsburgh, Pennsylvania, United States, 15218
Sponsors and Collaborators
Ono Pharma USA Inc
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Ono Pharma USA, Inc. Ono Pharmaceutical Co. Ltd
More Information

Responsible Party: Ono Pharma USA Inc
ClinicalTrials.gov Identifier: NCT01613703     History of Changes
Other Study ID Numbers: ONO-2952POU003
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013

Keywords provided by Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ):
ONO-2952
Healthy adult subjects
single doe
PET study
Safety
Tolerability