A Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of ONO-4053 in Healthy Volunteers
|ClinicalTrials.gov Identifier: NCT01537172|
Recruitment Status : Completed
First Posted : February 23, 2012
Last Update Posted : December 10, 2012
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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 :||January 2012|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
E Experimental Intervention 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||
Placebo to match ONO-4053 tablets, dosed in a similar manner to ONO-4053
- 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 ]
- Plasma and urine concentrations of ONO-4053 and derived pharmacokinetic parameters [ Time Frame: Day 17 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537172
|Hammersmith Medicines Research Ltd|
|London, United Kingdom, NW10 7EW|
|Study Director:||Clinical Department||Ono Pharmaceutical Co. Ltd|