This is a phase 1, open-label, randomized study. The objective of this study is to evaluate the PK, safety and tolerability of orally administered single-dose HRS-5041 in healthy Caucasian male participants.
The objective of this study is to evaluate the PK, safety and tolerability of orally administered single-dose HRS-5041 in healthy Caucasian male participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Single dose of HRS-5041 orally administered
Single dose of HRS-5041 orally administered
Nucleus Network Melbourne
Melbourne, Victoria, Australia
PK profile (Cmax) of HRS-5041 after a single oral (PO) administration:
Parameters: Cmax
Time frame: Day 10
PK profile (AUC0-t) of HRS-5041 after a single oral (PO) administration:
Parameter: AUC0-t
Time frame: Day 10
PK profile (AUC0-inf) of HRS-5041 after a single oral (PO) administration:
Parameter:AUC0-inf
Time frame: Day 10
PK profile (Tmax) of HRS-5041 after a single oral (PO) administration:
Parameter: Tmax
Time frame: Day 10
PK profile ( t1/2) of HRS-5041 after a single oral (PO) administration:
Parameter: t1/2
Time frame: Day 10
PK profile (CL/F) of HRS-5041 after a single oral (PO) administration:
Parameter: CL/F
Time frame: Day 10
PK profile (Vz/F) of HRS-5041 after a single oral (PO) administration:
Parameter: Vz/F
Time frame: Day 10
Safety and tolerability - number and severity of adverse events
Incidence and severity of AE
Time frame: Day 10
Safety and tolerability - Blood pressure
Incidence of Adverse Events and Abnormalities as assessed by blood pressure (systolic and diastolic pressure)
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Time frame: Day 10
Safety and tolerability - Body temperature
Incidence of Adverse Events and Abnormalities as assessed by body temperature
Time frame: Day 10
Safety and tolerability - Physical examination
Incidence of Adverse Events and Abnormalities as Assessed by Physical Examination
Time frame: Day 10
Safety and tolerability - Laboratory tests
Number of abnormalities assessed based on safety bloods and urine test
Time frame: Day 10
Safety and tolerability - ECG
heart rate, PR interval, QT interval, corrected QT (QTcF using Fridericia's formula) interval, and QRS
Time frame: Day 10