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A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers

NCT ID: NCT01537172

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Ono Pharma UK Ltd is the European subsidiary of Ono Pharmaceutical Co. Ltd. As the European Legal Representative of Ono Pharmaceutical Co. Ltd, Ono Pharma UK Ltd is carrying out this study.

This is a clinical study of ONO-4053 in healthy volunteers. This study consists of three parts. Part A will investigate the safety, tolerability and pharmacokinetics when single ascending doses of ONO-4053 are administered in a double-blind manner. Part B will investigate the pharmacokinetics of ONO-4053 in the fed and fasted state in an open-label manner. Part C will investigate the safety, tolerability and pharmacokinetics when multiple ascending doses of ONO-4053 are administered in a double-blind manner. Doses for Part B and C will be determined after data from Part A are available.

Conditions

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Healthy Adult Subjects

Keywords

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ONO-4053 healthy subjects 3 part adaptive design

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ONO-4053

E Experimental Intervention Drug: ONO-4053

Group Type EXPERIMENTAL

ONO-4053

Intervention Type DRUG

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.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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ONO-4053

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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Department

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

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Hammersmith Medicines Research Ltd

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ONO-4053POE002

Identifier Type: -

Identifier Source: org_study_id