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

February 13, 2012
December 7, 2012
January 2012
August 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01537172 on ClinicalTrials.gov Archive Site
Plasma and urine concentrations of ONO-4053 and derived pharmacokinetic parameters [ Time Frame: Day 17 ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy Adult Subjects
  • 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
  • Experimental: ONO-4053
    E Experimental Intervention Drug: ONO-4053
    Intervention: Drug: ONO-4053
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01537172
ONO-4053POE002
No
Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
Not Provided
Study Director: Clinical Department Ono Pharmaceutical Co. Ltd
Ono Pharmaceutical Co. Ltd
June 2012

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