NCT01379586

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of ONO-4053 across ascending single and multiple doses in healthy adult male and female subjects. The secondary objective of the study is to characterize the pharmacokinetic profile of ONO-4053 in healthy adult male and female subjects.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

1 month

First QC Date

June 21, 2011

Last Update Submit

June 12, 2012

Conditions

Healthy Adult Subjects

Keywords

ONO-4053Healthy adult subjectsFirst time in humans

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of ONO-4053 across ascending single and multiple doses using adverse events, vital signs, 12-lead ECG, continuous ECG monitoring and clinical lab tests.

    At protocol-specified timepoints before and after study drug administration up to Day 14

Secondary Outcomes (1)

  • Plasma and urine concentrations of ONO-4053 and derived pharmacokinetic parameters

    At protocol-specified timepoints before and after study drug administration up to Day 14

Study Arms (2)

E

EXPERIMENTAL

ONO-4053

Drug: ONO-4053

P

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

ONO-4053DRUG

Part A: ONO-4053 doses proposed are 1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 300 mg, 600 mg as a single dose administered by mouth once daily

E
PlaceboDRUG

Placebo to match ONO-4053 tablets dosed in a similar manner to ONO-4053

P

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy caucasian subjects aged 18-45 years inclusive
  • Subjects with a body mass index of 19-30 kg/m2 inclusive and who weigh at least 50 kg and no more than 100 kg at screening.

You may not qualify if:

  • Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder.
  • Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Clinical Site

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Location

Study Officials

  • Clinical Department

    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

June 21, 2011

First Posted

June 23, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2011

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

GB(1)