Status:
COMPLETED
Multiple-dose Study of FOY-305 in Japanese Healthy Adult Male Subjects
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
To investigate safety, tolerability and pharmacokinetics in Japanese healthy adult male subjects when FOY-305 is administered as multiple-dose orally.
Eligibility Criteria
Inclusion
- Japanese healthy adult male subjects
- Age (at the time of informed consent): ≥18 yeas, ≤ 45 yeas
- BMI (at the time of screening test): ≥18.5 kg/m2, \<25.0 kg/m2
Exclusion
- Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other 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
- Subjects with a history of hypersensitivity caused by ingredients of this drug
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04451083
Start Date
July 1 2020
End Date
August 17 2020
Last Update
April 9 2024
Active Locations (1)
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1
Fukuoka Clinical Site 01
Fukuoka, Japan, 812-0025