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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
  Purpose

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 Intervention Phase
Healthy Adult Subjects
 Drug: ONO-4053
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Ono Pharmaceutical Co. Ltd:

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

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

Enrollment: 80
Study Start Date: January 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537172

Locations
United Kingdom
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
  More Information

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT01537172     History of Changes
Other Study ID Numbers: ONO-4053POE002
Study First Received: February 13, 2012
Last Updated: December 7, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-4053 healthy subjects
3 part adaptive design

ClinicalTrials.gov processed this record on May 19, 2013