Status:
COMPLETED
Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and PK of ONO-2910 in Japanese and Caucasian Subjects
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Healthy Volunteers
Eligibility:
All Genders
20-74 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04504760
Start Date
July 10 2020
End Date
March 18 2021
Last Update
May 3 2024
Active Locations (1)
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1
Tokyo Clinical Site 01
Tokyo, Japan