To investigate safety, tolerability and pharmacokinetics in Japanese healthy adult male subjects when FOY-305 is administered as multiple-dose orally.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Multiple-dose of FOY-305 will be administered orally at 4 times/day.
Fukuoka Clinical Site 01
Fukuoka, Japan
Adverse events [Safety and Tolerability]
Number of participants with adverse events as assessed by CTCAE v5.0
Time frame: Up to 10 days
Vital sign [Safety and Tolerability]
Summary statistics of blood pressure
Time frame: Up to 10 days
Vital sign [Safety and Tolerability]
Summary statistics of pulse rate
Time frame: Up to 10 days
Vital sign [Safety and Tolerability]
Summary statistics of SpO2
Time frame: Up to 10 days
Body temperature [Safety and Tolerability]
Summary statistics of body temperature
Time frame: Up to 10 days
Body weight [Safety and Tolerability]
Summary statistics of body weight
Time frame: Up to 10 days
ECG parameter test [Safety and Tolerability]
Summary statistics of ECG parameter test (Heart Rate)
Time frame: Up to 10 days
ECG parameter test [Safety and Tolerability]
Summary statistics of ECG parameter test (RR)
Time frame: Up to 10 days
ECG parameter test [Safety and Tolerability]
Summary statistics of ECG parameter test (PR)
Time frame: Up to 10 days
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ECG parameter test [Safety and Tolerability]
Summary statistics of ECG parameter test (QRS)
Time frame: Up to 10 days
ECG parameter test [Safety and Tolerability]
Summary statistics of ECG parameter test (QT)
Time frame: Up to 10 days
ECG parameter test [Safety and Tolerability]
Summary statistics of ECG parameter test (QTcF)
Time frame: Up to 10 days
Laboratory test [Safety and Tolerability]
Summary statistics of laboratory test (hematologic test)
Time frame: Up to 10 days
Laboratory test [Safety and Tolerability]
Summary statistics of laboratory test (blood biochemistry test)
Time frame: Up to 10 days
Laboratory test [Safety and Tolerability]
Summary statistics of laboratory test (blood coagulation test)
Time frame: Up to 10 days
Laboratory test [Safety and Tolerability]
Summary statistics of laboratory test (urinalysis)
Time frame: Up to 10 days
Cmax of FOY-251 [Pharmacokinetic]
Assessment of the Cmax of FOY-251 (Active metabolite of FOY-305)
Time frame: Up to 10 days
Tmax of FOY-251 [Pharmacokinetic]
Assessment of the Tmax of FOY-251 (Active metabolite of FOY-305)
Time frame: Up to 10 days
AUC of FOY-251 [Pharmacokinetic]
Assessment of the AUC4h of FOY-251 (Active metabolite of FOY-305)
Time frame: Up to 10 days
AUC of FOY-251 [Pharmacokinetic]
Assessment of the AUClast of FOY-251 (Active metabolite of FOY-305)
Time frame: Up to 10 day
AUC of FOY-251 [Pharmacokinetic]
Assessment of the AUCinf of FOY-251 (Active metabolite of FOY-305)
Time frame: Up to 10 days
T1/2 of FOY-251 [Pharmacokinetic]
Assessment of the T1/2 of FOY-251 (Active metabolite of FOY-305)
Time frame: Up to 10 days
CL/F of FOY-251 [Pharmacokinetic]
Assessment of the CL of FOY-251 (Active metabolite of FOY-305)
Time frame: Up to 10 days