Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects

Study Overview
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Brief Summary
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To investigate safety, tolerability and pharmacokinetics in Japanese and Caucasian subjects when ONO-2910 is administered as single and multiple doses orally.

Detailed Description
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This study is the First in Human (FIH) study to investigate safety, tolerability and pharmacokinetics in healthy Japanese and Caucasian adult male subjects when ONO-2910 is administered as single and multiple doses orally. Also, the purpose of this study is to evaluate pharmacokinetics of oral single-dose of ONO-2910 in Japanese elderly male and female subjects.

Official Title
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Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ONO-2910
* Drug: Placebo
* Drug: ONO-2910
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese healthy adult male subjects (Part A and C) Japanese men or women after menopause aged ≥65 years and ≤74 years (Part B) Caucasian healthy adult male subjects (Part D) Age (at the time of informed consent): ≥20 years, ≤ 45 years (Part A, C and D) Exclusion Criteria: Subjects currently with or with a history of disease Subjects with current or with a history of severe allergy to drugs or foods Subjects with current or with a history of drug or alcohol abuse

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ONO-2910 (Part A and B)<br> | Drug: ONO-2910<br>* Single ascending dose of ONO-2910 will be administered orally.<br>|
| Placebo Comparator: Placebo (Part A)<br> | Drug: Placebo<br>* Single dose of placebo will be administered orally.<br>|
| Experimental: ONO-2910 (Part C and D)<br> | Drug: ONO-2910<br>* Multiple ascending dose of ONO-2910 will be administered orally.<br>|
| Placebo Comparator: Placebo (Part C and D)<br> | Drug: Placebo<br>* Multiple dose of placebo will be administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events [Safety and Tolerability] | Number of participants with adverse events as assessed by CTCAE v5.0 | Up to 13 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax [Pharmacokinetic] | Assessment of the Cmax of ONO-2910 | Up to 10 days | 
| Tmax [Pharmacokinetic] | Assessment of the Tmax of ONO-2910 | Up to 10 days | 
| AUC24h [Pharmacokinetic] | Assessment of the AUC24h of ONO-2910 | Up to 10 days | 
| AUClast [Pharmacokinetic] | Assessment of the AUClast of ONO-2910 | Up to 10 days | 
| AUCinf [Pharmacokinetic] | Assessment of the AUCinf of ONO-2910 | Up to 10 days | 
| T1/2 [Pharmacokinetic] | Assessment of the T1/2 of ONO-2910 | Up to 10 days | 
| CL/F [Pharmacokinetic] | Assessment of the CL/F of ONO-2910 | Up to 10 days | 
| fe [Pharmacokinetic] | Assessment of the Vss of ONO-2910 | Up to 4 days | 
| CLr [Pharmacokinetic] | Assessment of the CLr of ONO-2910 | Up to 4 days |