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NCT01613703 Clinical Trial

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

Healthy Adult Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01613703
Other study ID # ONO-2952POU003
Secondary ID
Status Completed
Phase Phase 1
First received June 5, 2012
Last updated May 31, 2013
Start date August 2012

Study information
Verified date May 2013
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-2952
1 mg to 200 mg QD at a single descending dose

Locations
Country Name City State
United States Pittsburgh Clinical Site Pittsburgh Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Ono Pharma USA Inc Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 2 days Yes
Secondary To evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952 2 days No
Secondary To investigate the safety and tolerability of ONO-2952 in healthy adult subjects 14 days Yes
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