Healthy Volunteers
Conditions
Brief summary
To investigate safety, tolerability and pharmacokinetics in Japanese and Caucasian subjects when ONO-2910 is administered as single and multiple doses orally.
Detailed description
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.
Interventions
DRUGONO-2910
Single ascending dose of ONO-2910 will be administered orally.
DRUGPlacebo
Single dose of placebo will be administered orally.
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events [Safety and Tolerability] | Up to 13 days | Number of participants with adverse events as assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCinf [Pharmacokinetic] | Up to 10 days | Assessment of the AUCinf of ONO-2910 |
| T1/2 [Pharmacokinetic] | Up to 10 days | Assessment of the T1/2 of ONO-2910 |
| CL/F [Pharmacokinetic] | Up to 10 days | Assessment of the CL/F of ONO-2910 |
| fe [Pharmacokinetic] | Up to 4 days | Assessment of the Vss of ONO-2910 |
| AUClast [Pharmacokinetic] | Up to 10 days | Assessment of the AUClast of ONO-2910 |
| AUC24h [Pharmacokinetic] | Up to 10 days | Assessment of the AUC24h of ONO-2910 |
| Cmax [Pharmacokinetic] | Up to 10 days | Assessment of the Cmax of ONO-2910 |
| Tmax [Pharmacokinetic] | Up to 10 days | Assessment of the Tmax of ONO-2910 |
| CLr [Pharmacokinetic] | Up to 4 days | Assessment of the CLr of ONO-2910 |
Countries
Japan
Outcome results
None listed