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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Tokyo Clinical Site 01
Tokyo, Japan
Adverse events [Safety and Tolerability]
Number of participants with adverse events as assessed by CTCAE v5.0
Time frame: Up to 13 days
Cmax [Pharmacokinetic]
Assessment of the Cmax of ONO-2910
Time frame: Up to 10 days
Tmax [Pharmacokinetic]
Assessment of the Tmax of ONO-2910
Time frame: Up to 10 days
AUC24h [Pharmacokinetic]
Assessment of the AUC24h of ONO-2910
Time frame: Up to 10 days
AUClast [Pharmacokinetic]
Assessment of the AUClast of ONO-2910
Time frame: Up to 10 days
AUCinf [Pharmacokinetic]
Assessment of the AUCinf of ONO-2910
Time frame: Up to 10 days
T1/2 [Pharmacokinetic]
Assessment of the T1/2 of ONO-2910
Time frame: Up to 10 days
CL/F [Pharmacokinetic]
Assessment of the CL/F of ONO-2910
Time frame: Up to 10 days
fe [Pharmacokinetic]
Assessment of the Vss of ONO-2910
Time frame: Up to 4 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Multiple dose of placebo will be administered orally.
CLr [Pharmacokinetic]
Assessment of the CLr of ONO-2910
Time frame: Up to 4 days