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Clinical Trial Details

Trial ID: L3753
Source ID: NCT06137469
Associated Drug: Acetaminophen/Shr20004
Title: Assessment of Gastric Emptying by SHR20004 in Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Acetaminophen/SHR20004|DRUG: Acetaminophen/Placebo
Outcome Measures: Primary: Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.:(AUC0-300min), Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31 | Secondary: Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (AUC0-60min), 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), 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), 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), 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), 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), 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.: (Vz/F), Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31|Incidence and severity of AE/SAE/AESI., 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., 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., 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., 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., 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., Day 1 and Day 10 and Day 30 and Day 36|Immunogenicity indicators: anti-Noiiglutide antibodies, Start of treatment up to Day 50
Sponsor/Collaborators: Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 28
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2023-12-26
Completion Date: 2024-03-16
Results First Posted:
Last Update Posted: 2024-12-02
Locations: Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210008, China
URL: https://clinicaltrials.gov/show/NCT06137469