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

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

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

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.

Inclusion Criteria:

1. Japanese healthy adult male subjects (Part A and C)
2. Japanese men or women after menopause aged ≥65 years and ≤74 years (Part B)
3. Caucasian healthy adult male subjects (Part D)
4. Age (at the time of informed consent): ≥20 years, ≤ 45 years (Part A, C and D)

Exclusion Criteria:

1. Subjects currently with or with a history of disease
2. Subjects with current or with a history of severe allergy to drugs or foods
3. Subjects with current or with a history of drug or alcohol abuse