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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Adult Subjects

Intervention / Treatment
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* Drug: ONO-4053
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ONO-4053<br>E Experimental Intervention Drug: ONO-4053 | Drug: ONO-4053<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo to match ONO-4053 tablets, dosed in a similar manner to ONO-4053<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma and urine concentrations of ONO-4053 and derived pharmacokinetic parameters |  | Day 17 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ONO-4053 healthy subjects, 3 part adaptive design