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

This study has been completed.
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT01613703
First received: June 5, 2012
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Healthy Adult Subjects
Drug: ONO-2952
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952 [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • To investigate the safety and tolerability of ONO-2952 in healthy adult subjects [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: August 2012
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Drug: ONO-2952
1 mg to 200 mg QD at a single descending dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT01613703     History of Changes
Other Study ID Numbers: ONO-2952POU003
Study First Received: June 5, 2012
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 23, 2014