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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014