NCT01537172

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

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2012

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

December 10, 2012

Status Verified

June 1, 2012

Enrollment Period

7 months

First QC Date

February 13, 2012

Last Update Submit

December 7, 2012

Conditions

Healthy Adult Subjects

Keywords

ONO-4053 healthy subjects3 part adaptive design

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.

    Day 17

Secondary Outcomes (1)

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

    Day 17

Study Arms (2)

ONO-4053

EXPERIMENTAL

E Experimental Intervention Drug: ONO-4053

Drug: ONO-4053

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ONO-4053DRUG

Part A: ONO-4053 doses proposed are 10 mg, 30 mg, 100 mg, 300 mg, 600 mg, 900 mg as a single dose administered by mouth once daily, depending on the outcome of the previous dose.

ONO-4053
PlaceboDRUG

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

Placebo

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)

Hammersmith Medicines Research Ltd

London, NW10 7EW, 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

February 13, 2012

First Posted

February 23, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

December 10, 2012

Record last verified: 2012-06

Locations

GB(1)