Clinical trial NCT04451083: Multiple-dose Study of FOY-305 in Japanese Healthy Adult Male Subjects
Official title: Multiple-dose Study of FOY-305 in Japanese Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2020-06-30
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Criteria:

1. Japanese healthy adult male subjects
2. Age (at the time of informed consent): ≥18 yeas, ≤ 45 yeas
3. BMI (at the time of screening test): ≥18.5 kg/m2, \<25.0 kg/m2

Exclusion Criteria:

1. 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.
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
4. Subjects with a history of hypersensitivity caused by ingredients of this drug

Primary outcomes:
measure: Adverse events [Safety and Tolerability]
timeFrame: Up to 10 days
measure: Vital sign [Safety and Tolerability]
timeFrame: Up to 10 days
measure: Vital sign [Safety and Tolerability]
timeFrame: Up to 10 days
measure: Vital sign [Safety and Tolerability]
timeFrame: Up to 10 days
measure: Body temperature [Safety and Tolerability]
timeFrame: Up to 10 days
measure: Body weight [Safety and Tolerability]
timeFrame: Up to 10 days
measure: ECG parameter test [Safety and Tolerability]
timeFrame: Up to 10 days
measure: ECG parameter test [Safety and Tolerability]
timeFrame: Up to 10 days
measure: ECG parameter test [Safety and Tolerability]
timeFrame: Up to 10 days
measure: ECG parameter test [Safety and Tolerability]
timeFrame: Up to 10 days
measure: ECG parameter test [Safety and Tolerability]
timeFrame: Up to 10 days
measure: ECG parameter test [Safety and Tolerability]
timeFrame: Up to 10 days
measure: Laboratory test [Safety and Tolerability]
timeFrame: Up to 10 days
measure: Laboratory test [Safety and Tolerability]
timeFrame: Up to 10 days
measure: Laboratory test [Safety and Tolerability]
timeFrame: Up to 10 days
measure: Laboratory test [Safety and Tolerability]
timeFrame: Up to 10 days
Secondary outcomes:
measure: Cmax of FOY-251 [Pharmacokinetic]
timeFrame: Up to 10 days
measure: Tmax of FOY-251 [Pharmacokinetic]
timeFrame: Up to 10 days
measure: AUC of FOY-251 [Pharmacokinetic]
timeFrame: Up to 10 days
measure: AUC of FOY-251 [Pharmacokinetic]
timeFrame: Up to 10 day
measure: AUC of FOY-251 [Pharmacokinetic]
timeFrame: Up to 10 days
measure: T1/2 of FOY-251 [Pharmacokinetic]
timeFrame: Up to 10 days
measure: CL/F of FOY-251 [Pharmacokinetic]
timeFrame: Up to 10 days
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Fukuoka Clinical Site 01
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Susumu Nakade
role: STUDY_DIRECTOR
References: