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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ono Pharmaceutical Co. Ltd

ClinicalTrials.gov Identifier:

NCT01537172

First received: February 13, 2012

Last updated: December 7, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 13, 2012

Last Updated Date

December 7, 2012

Start Date ^ICMJE

January 2012

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: Day 17 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01537172 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Plasma and urine concentrations of ONO-4053 and derived pharmacokinetic parameters [ Time Frame: Day 17 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Plasma and urine concentrations of ONO-4053 and derived pharmacokinetic parameters [ Time Frame: Day 17 ] [ Designated as safety issue: No ]

Part A: 15 timepoints up to Day 4. Part B: 30(15X2) timepoints up to Day 4. Part C: 30 timepoints up to Day 17.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase 1, Single Centre, Three-part, Randomised, Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single and Multiple Ascending Doses of Oral ONO-4053 and the Effects of Food in Healthy Males and Females

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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Healthy Adult Subjects

Intervention ^ICMJE

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

Study Arm (s)

Experimental: ONO-4053
E Experimental Intervention Drug: ONO-4053

Intervention: Drug: ONO-4053
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2012

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01537172

Other Study ID Numbers ^ICMJE

ONO-4053POE002

Has Data Monitoring Committee

Responsible Party

Ono Pharmaceutical Co. Ltd

Study Sponsor ^ICMJE

Ono Pharmaceutical Co. Ltd

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Department

Ono Pharmaceutical Co. Ltd

Information Provided By

Ono Pharmaceutical Co. Ltd

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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