Multiple-dose Study of FOY-305 in Japanese Healthy Adult Male Subjects

Study Overview
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Brief Summary
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To investigate safety, tolerability and pharmacokinetics in Japanese healthy adult male subjects when FOY-305 is administered as multiple-dose orally.

Official Title
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Multiple-dose Study of FOY-305 in Japanese Healthy Adult Male Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: FOY-305


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOY-305<br> | Drug: FOY-305<br>* Multiple-dose of FOY-305 will be administered orally at 4 times/day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events [Safety and Tolerability] | Number of participants with adverse events as assessed by CTCAE v5.0 | Up to 10 days | 
| Vital sign [Safety and Tolerability] | Summary statistics of blood pressure | Up to 10 days | 
| Vital sign [Safety and Tolerability] | Summary statistics of pulse rate | Up to 10 days | 
| Vital sign [Safety and Tolerability] | Summary statistics of SpO2 | Up to 10 days | 
| Body temperature [Safety and Tolerability] | Summary statistics of body temperature | Up to 10 days | 
| Body weight [Safety and Tolerability] | Summary statistics of body weight | Up to 10 days | 
| ECG parameter test [Safety and Tolerability] | Summary statistics of ECG parameter test (Heart Rate) | Up to 10 days | 
| ECG parameter test [Safety and Tolerability] | Summary statistics of ECG parameter test (RR) | Up to 10 days | 
| ECG parameter test [Safety and Tolerability] | Summary statistics of ECG parameter test (PR) | Up to 10 days | 
| ECG parameter test [Safety and Tolerability] | Summary statistics of ECG parameter test (QRS) | Up to 10 days | 
| ECG parameter test [Safety and Tolerability] | Summary statistics of ECG parameter test (QT) | Up to 10 days | 
| ECG parameter test [Safety and Tolerability] | Summary statistics of ECG parameter test (QTcF) | Up to 10 days | 
| Laboratory test [Safety and Tolerability] | Summary statistics of laboratory test (hematologic test) | Up to 10 days | 
| Laboratory test [Safety and Tolerability] | Summary statistics of laboratory test (blood biochemistry test) | Up to 10 days | 
| Laboratory test [Safety and Tolerability] | Summary statistics of laboratory test (blood coagulation test) | Up to 10 days | 
| Laboratory test [Safety and Tolerability] | Summary statistics of laboratory test (urinalysis) | Up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of FOY-251 [Pharmacokinetic] | Assessment of the Cmax of FOY-251 (Active metabolite of FOY-305) | Up to 10 days | 
| Tmax of FOY-251 [Pharmacokinetic] | Assessment of the Tmax of FOY-251 (Active metabolite of FOY-305) | Up to 10 days | 
| AUC of FOY-251 [Pharmacokinetic] | Assessment of the AUC4h of FOY-251 (Active metabolite of FOY-305) | Up to 10 days | 
| AUC of FOY-251 [Pharmacokinetic] | Assessment of the AUClast of FOY-251 (Active metabolite of FOY-305) | Up to 10 day | 
| AUC of FOY-251 [Pharmacokinetic] | Assessment of the AUCinf of FOY-251 (Active metabolite of FOY-305) | Up to 10 days | 
| T1/2 of FOY-251 [Pharmacokinetic] | Assessment of the T1/2 of FOY-251 (Active metabolite of FOY-305) | Up to 10 days | 
| CL/F of FOY-251 [Pharmacokinetic] | Assessment of the CL of FOY-251 (Active metabolite of FOY-305) | Up to 10 days |