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

Sponsor

Ono Pharmaceutical Co. Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT01537172

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Adult Subjects	Drug: ONO-4053 Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ONO-4053 E Experimental Intervention Drug: ONO-4053	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.
Placebo Comparator: Placebo	Drug: Placebo Placebo to match ONO-4053 tablets, dosed in a similar manner to ONO-4053

Arm

Intervention/Treatment

Experimental: ONO-4053

E Experimental Intervention Drug: ONO-4053

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.

Placebo Comparator: Placebo

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Plasma and urine concentrations of ONO-4053 and derived pharmacokinetic parameters [Day 17]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hammersmith Medicines Research Ltd	London		United Kingdom	NW10 7EW

Sponsors and Collaborators

Ono Pharmaceutical Co. Ltd

Investigators

Study Director: Clinical Department, Ono Pharmaceutical Co. Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ono Pharmaceutical Co. Ltd

ClinicalTrials.gov Identifier:

NCT01537172

Other Study ID Numbers:

ONO-4053POE002

First Posted:

Feb 23, 2012

Last Update Posted:

Dec 10, 2012

Last Verified:

Jun 1, 2012

Keywords provided by Ono Pharmaceutical Co. Ltd

ONO-4053 healthy subjects

3 part adaptive design

Study Results

No Results Posted as of Dec 10, 2012