Healthy Volunteers
Conditions
Brief summary
To investigate safety, tolerability and pharmacokinetics in Japanese healthy adult male subjects when FOY-305 is administered as multiple-dose orally.
Interventions
DRUGFOY-305
Multiple-dose of FOY-305 will be administered orally at 4 times/day.
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory test [Safety and Tolerability] | Up to 10 days | Summary statistics of laboratory test (hematologic test) |
| Adverse events [Safety and Tolerability] | Up to 10 days | Number of participants with adverse events as assessed by CTCAE v5.0 |
| Vital sign [Safety and Tolerability] | Up to 10 days | Summary statistics of blood pressure |
| Body temperature [Safety and Tolerability] | Up to 10 days | Summary statistics of body temperature |
| Body weight [Safety and Tolerability] | Up to 10 days | Summary statistics of body weight |
| ECG parameter test [Safety and Tolerability] | Up to 10 days | Summary statistics of ECG parameter test (Heart Rate) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax of FOY-251 [Pharmacokinetic] | Up to 10 days | Assessment of the Tmax of FOY-251 (Active metabolite of FOY-305) |
| AUC of FOY-251 [Pharmacokinetic] | Up to 10 days | Assessment of the AUC4h of FOY-251 (Active metabolite of FOY-305) |
| T1/2 of FOY-251 [Pharmacokinetic] | Up to 10 days | Assessment of the T1/2 of FOY-251 (Active metabolite of FOY-305) |
| CL/F of FOY-251 [Pharmacokinetic] | Up to 10 days | Assessment of the CL of FOY-251 (Active metabolite of FOY-305) |
| Cmax of FOY-251 [Pharmacokinetic] | Up to 10 days | Assessment of the Cmax of FOY-251 (Active metabolite of FOY-305) |
Countries
Japan
Outcome results
None listed