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Clinical Trial Details

Trial ID: L1345
Source ID: NCT06648876
Associated Drug: Yg1699
Title: PK and PD of YG1699 in CKD Patients With Diabetes
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes|Renal Insufficiency, Chronic|Hemodialysis
Interventions: DRUG: YG1699|DRUG: Placebo
Outcome Measures: Primary: YG1699 concentration in plasma at different time, single-dose pharmacokinetic, 0 hour (h), 0.5h, 1h, 2h, 4h, 8h and 12h after the first dose of YG1699 (Day1); 24 hours after the first dose of YG1699 (Day2 morning) | Secondary: Metabolite 1 concentration in plasma at different time, single-dose pharmacokinetic, 0 hour (h), 0.5h, 1h, 2h, 4h, 8h and 12h after the first dose of YG1699 (Day1); 24 hours after the first dose of YG1699 (Day2 morning)|YG1699 steady-state concentration in plasma, steady-state pharmacokinetic, Day 9 morning(the first day after discontinuation of the drug)|Metabolite 1 steady-state concentration in plasma, steady-state pharmacokinetic, Day 9 morning(the first day after discontinuation of the drug)|Hemodialysis clearance of YG1699, pharmacokinetic, immediately before and immediately after the hemodialysis treatment on Day9|Hemodialysis clearance of Metabolite 1, pharmacokinetic, immediately before and immediately after the hemodialysis treatment on Day 9|OGTT, 0h, 1h, 2h, 3h blood glucose after taking 75g oral glucose, screen period and Day 8 (last day of medication)|24h urine glucose, screen period and Day 8 (last day of medication) | Other: Red blood cell count, Day9 morning(the first day after discontinuation of the drug)|White blood cell count, Day 9 morning(the first day after discontinuation of the drug)|Platelet count, Day 9 morning(the first day after discontinuation of the drug)|Hemoglobin, Day 9 morning(the first day after discontinuation of the drug)|Alanine aminotransaminase (ALT), Day 9 morning(the first day after discontinuation of the drug)|Aspartate aminotransferase (AST), Day 9 morning(the first day after discontinuation of the drug)|Total bilirubin, Day 9 morning(the first day after discontinuation of the drug)|Direct bilirubin, Day 9 morning(the first day after discontinuation of the drug)|Blood ketone body, Day 9 morning(the first day after discontinuation of the drug)|Blood pH, Day 9 morning(the first day after discontinuation of the drug)|Blood HCO3- concentration, Day 9 morning(the first day after discontinuation of the drug)|Serum creatinine, Day 9 morning(the first day after discontinuation of the drug)|estimated glomerular filtration rate (eGFR), Day 9 morning(the first day after discontinuation of the drug)|Urinary albumin/creatinine ratio (UACR), Day 9 morning(the first day after discontinuation of the drug)|ECG heart rate, Day 9 morning(the first day after discontinuation of the drug)|ECG heart rhythm, Day 9 morning(the first day after discontinuation of the drug)|ECG PR interval, Day 9 morning(the first day after discontinuation of the drug)|ECG QT interval, Day 9 morning(the first day after discontinuation of the drug)
Sponsor/Collaborators: Sponsor: RenJi Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-31
Completion Date: 2025-10-30
Results First Posted:
Last Update Posted: 2024-10-18
Locations: Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200127, China
URL: https://clinicaltrials.gov/show/NCT06648876