NCT04504760

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Ono Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ONO-2910	Single ascending dose of ONO-2910 will be administered orally.
DRUG	Placebo	Single dose of placebo will be administered orally.
DRUG	ONO-2910	Multiple ascending dose of ONO-2910 will be administered orally.
DRUG	Placebo	Multiple dose of placebo will be administered orally.

Timeline

• Start date: 2020-07-10
• Primary completion: 2021-03-18
• Completion: 2021-03-18
• First posted: 2020-08-07
• Last updated: 2024-05-03

Locations

1 site across 1 country: Japan