NCT01489345

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending multiple doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

4 months

First QC Date

December 7, 2011

Last Update Submit

July 31, 2012

Conditions

Healthy

Keywords

ONO-2952Healthy adult subjectsMultiple doseSafetyTolerabilityPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of ONO-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events

    36 days

Secondary Outcomes (1)

  • Characterization of PK of ONO-2952 in plasma samples

    36 days

Study Arms (2)

Arm 1: Experimental

EXPERIMENTAL
Drug: ONO-2952

Arm 2: Placebo Comparator

PLACEBO COMPARATOR
Drug: ONO-2952 Matching Placebo

Interventions

ONO-2952DRUG

30 mg to 100 mg QD at a multiple dose, and 21 days duration

Arm 1: Experimental
ONO-2952 Matching PlaceboDRUG

30 mg to 100 mg QD at a multiple dose, and 21 days duration

Arm 2: Placebo Comparator

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • History or presence of clinically significant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Clinical Site

Austin, Texas, 78744, United States

Location

Related Publications (1)

  • Suto F, Wood AT, Kobayashi M, Komaba J, Duffy K, Bruce M. Safety, Tolerability, and Pharmacokinetic Profile of the Novel Translocator Protein 18 kDa Antagonist ONO-2952 in Healthy Volunteers. Clin Ther. 2015 Sep;37(9):2071-84. doi: 10.1016/j.clinthera.2015.07.010. Epub 2015 Aug 4.

    PMID: 26249232DERIVED

MeSH Terms

Interventions

ONO-2952

Study Officials

  • Ono Pharma USA, Inc

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2011

First Posted

December 9, 2011

Study Start

December 1, 2011

Primary Completion

April 1, 2012

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(1)