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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOY-305 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOY-305 | Drug | Multiple-dose of FOY-305 will be administered orally at 4 times/day. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susumu Nakade | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka Clinical Site 01 | Fukuoka | 812-0025 | Japan |
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| ID | Term |
|---|---|
| C034532 | camostat |
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| 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 |
| 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 |