PK and PD of YG1699 in CKD Patients With Diabetes (NCT06648876) | Clinical Trial Compass
Not Yet RecruitingPhase 1
PK and PD of YG1699 in CKD Patients With Diabetes
China20 participantsStarted 2024-10-31
Plain-language summary
The goal of this clinical trial is to learn PK and PD of YG1699 in patients with diabetes and renal dysfuction.
Participants will:
Take YG1699 or a placebo every day for 8 days. Visit the clinic 7 times for checkups and tests. Keep a diary of their symptoms. Estimate PK data from a single dose of YG1699. Estimate PD data at baseline and the last day.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Ability to provide informed consent
✓. Male or female patients ,age between 18 and 70 at screening
✓. Meet the diagnostic criteria for diabetic nephropathy, including patients with type 1 or type 2 diabetes;
✓. Hemodialysis patients must have maintenance hemodialysis for more than 3 months, with 3 sessions per week (limited to HD or HDF treatment), and spKt/V\>1.2 within 6 months
✓. The patient has not used glucocorticoids, calcineurin inhibitors (cyclosporine, tacrolimus), etc. that affect blood sugar within the past month before signing the informed consent form
✓. The baseline diabetes management medication regimen has been stable within the past 2 weeks.
Exclusion criteria
✕. Hypoglycemia occurs more than 2 times in one month
✕. History of ketoacidosis
✕. Patients who are being treated with swiram and digoxin
✕. Patients with acute kidney injury (serum creatinine increased by ≥ 50% within 1 week)
✕
What they're measuring
1
YG1699 concentration in plasma at different time
Timeframe: 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)