The purpose of this study is to investigate the impact of SHR20004 on the pharmacokinetic (PK) characteristics of acetaminophen in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
28
SHR20004 was administered by titration, with all subjects starting on Day 4 with an initial dose of 0.03 mg/d of SHR20004 or placebo, with the dose being increased by 0.03 mg/d per week. The dose was increased to 0.15 mg/d and then maintained for 5 days.
Placebo was administered by titration, with all subjects starting on Day 4 with an initial dose of 0.03 mg/d of SHR20004 or placebo, with the dose being increased by 0.03 mg/d per week. The dose was increased to 0.15 mg/d and then maintained for 5 days.
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.:(AUC0-300min)
Time frame: Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31
Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (AUC0-60min)
Time frame: Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31
Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (AUC0-60min/AUC0-300min)
Time frame: Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31
Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (Cmax)
Time frame: Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31
Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (Tmax)
Time frame: Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31
Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (t1/2)
Time frame: Based on pre-dose to min post-dose sampling times on Day 1 and Day 31
Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (CL/F)
Time frame: Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31
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Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (Vz/F)
Time frame: Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31
Incidence and severity of AE/SAE/AESI.
Time frame: Screening period up to Day 50
Electrocardiographic parameters Fridericia-corrected QT interval (QTcF)
Mean QTcF as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings.
Time frame: Day 1 and Day 10 and Day 30 and Day 36
Delta QTcF
Mean change from baseline in QTcF as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings after study drug intake.
Time frame: Day 1 and Day 10 and Day 30 and Day 36
Double-delta QTcF (ΔΔQTcF)
Mean change from baseline and placebo in QTcF as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings after study drug intake.
Time frame: Day 1 and Day 10 and Day 30 and Day 36
Concentration-delta QTcF Correlation
Correlation between SHR20004 plasma concentration and delta QTcF based on appropriate regression model.
Time frame: Day 1 and Day 10 and Day 30 and Day 36
Concentration-double-delta QTcF Correlation
Correlation between SHR20004 plasma concentration and double-delta QTcF based on appropriate regression model.
Time frame: Day 1 and Day 10 and Day 30 and Day 36
Immunogenicity indicators: anti-Noiiglutide antibodies
Time frame: Start of treatment up to Day 50