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Clinical Trial Details

Trial ID: L7332
Source ID: NCT05642377
Associated Drug: Hgr4113
Title: A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Food Effect of HGR4113 in Healthy Subjects
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: HGR4113|DRUG: Placebo|DRUG: HGR4113|DRUG: Placebo
Outcome Measures: Primary: Safety and Tolerability Assessment by Adverse Event Monitoring, Number of participants with observed adverse events, Day 1 to 7 days after day of last administration|Safety and Tolerability Assessment by Number of Patients with Change in Physical Examination, Number of participants with clinically significant change in physical examination, Day 1 to 7 days after day of last administration|Safety and Tolerability Assessment by Number of Participants with Change in Vital Signs, Number of participants with clinically significant change in vital signs including blood pressure, heart rate, and body temperature, Day 1 to 7 days after day of last administration|Safety and Tolerability Assessment by Number of Participants with Change in Laboratory Test, Number of participants with clinically significant change in laboratory test assessed through hematology, blood biochemistry, urinalysis, blood coagulation, and hormone tests, Day 1 to 7 days after day of last administration|Safety and Tolerability Assessment by Number of Participants with Change in 12-Lead Electrocardiogram, Number of participants with clinically significant change in 12-lead electrocardiogram, Day 1 to 7 days after day of last administration|Safety and Tolerability Assessment by Number of Participants with Change in Semen Parameters, Number of participants with clinically significant change in semen assessed through semen volume, semen pH, sperm count, sperm concentration, sperm motility, and sperm morphology, From Screening to 12 weeks after day of last administration|Pharmacokinetic Assessment by Maximum Plasma Concentration of HGR4113, Maximum Plasma Concentration of HGR4113 (Cmax), Hour 0 to 96|Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HGR4113 Over Dosing Interval, Area Under the Plasma Concentration-Time Curve of HGR4113 Over Dosing Interval (AUCtau), Hour 0 to 24|Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HGR4113 from Time Zero to the Last Measurable Point, Area Under the Plasma Concentration-Time Curve of HGR4113 from Time Zero to the Last Measurable Point (AUClast), Hour 0 to 96|Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HGR4113 from Time Zero to Infinity, Area Under the Plasma Concentration-Time Curve of HGR4113 from Time Zero to Infinity (AUCinf), Hour 0 to 96|Pharmacokinetic Assessment by Half-Life of HGR4113, Half-life of HGR4113 (T1/2), Hour 0 to 96|Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HGR4113, Time to Maximum Observed Plasma of HGR4113 (Tmax), Hour 0 to 96|Pharmacokinetic Assessment by Oral Clearance of HGR4113, Oral Clearance of HGR4113 (CL/F), Hour 0 to 96|Pharmacokinetic Assessment by Apparent Volume of Distribution of HGR4113, Volume of Distribution of HGR4113 (Vz/F), Hour 0 to 96 | Secondary: Pharmacodynamic Assessment by Change in Paraoxonase 1 Activity, Change in paraoxonase 1 activity, Day -1 to 17|Pharmacodynamic Assessment by Change in Plasma Glucose, Change in plasma glucose level, Day -1 to 17|Pharmacodynamic Assessment by Change in Plasma HbA1c, Change in plasma HbA1c level, Day -1 to 17|Pharmacodynamic Assessment by Change in Plasma Insulin, Change in plasma insulin level, Day -1 to 17|Pharmacodynamic Assessment by Change in Plasma C-peptide, Change in plasma c-peptide level, Day -1 to 17
Sponsor/Collaborators: Sponsor: Glaceum | Collaborators: Seoul National University Hospital
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2022-11-22
Completion Date: 2025-01-31
Results First Posted:
Last Update Posted: 2024-03-21
Locations: Seoul National University Hospital, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT05642377