NCT01364441

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

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

May 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

3 months

First QC Date

May 25, 2011

Last Update Submit

June 12, 2012

Conditions

Healthy Adult Subjects

Keywords

ONO-2950healthy adult subjectsfirst in humansafetytolerabilitypharmacokinetics

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

    up to 8 days

Secondary Outcomes (2)

  • Characterization of PK of ONO-2952 through measurement of drug concentration in plasma and urine sample

    up to 8 days

  • Effect of food on ONO-2952 pharmacokinetics by comparison of PK profile between fasted and fed conditions

    up to 24 days

Study Arms (2)

P

PLACEBO COMPARATOR
Drug: Placebo

E

EXPERIMENTAL
Drug: ONO-2952

Interventions

ONO-2952DRUG

3 mg to 800 mg at a single dose; 10 mg and 200 mg for food effect study

E
PlaceboDRUG

Placebo dosed in the same manner as ONO-2952

P

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

May 25, 2011

First Posted

June 2, 2011

Study Start

May 1, 2011

Primary Completion

August 1, 2011

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

US(1)